Brain Injury, ChronicNCT04949607
Traumatic Brain Injury and the Gut Microbiome
A study testing Inulin fructooligosaccharide in people with Brain Injury, Chronic and Brain Injuries, Traumatic, run by Centre for Neuro Skills at 1 site in United States.
Trial summary
The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Chronic, Brain Injuries, Traumatic
- What is being tested?
- Inulin fructooligosaccharide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Traumatic Brain Injury
- Head trauma greater than two years prior manifesting in one or more of the following:
- Loss of consciousness
- Post-traumatic amnesia
- Focal neurologic deficits
- Seizures
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- Persistent symptoms of increased arousal (e.g., difficulty falling or staying asleep, anger and hypervigilance)
- Impairment in cognitive, social, occupational, or other important areas of functioning (e.g., problems with work and relationships)
- Healthy Control
- Ages 18 to 70 years
- Works at Centre for Neuro Skills
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Traumatic Brain Injury
- Unwilling to give consent. Patients with rights managed by Legal Authorized Representative must consent to participate in addition to consent from their legal agent
- < 2 years post-injury
- Known allergy to study agent.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
- Healthy Control
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- Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
- Known allergy to study agent.
- Other medical condition or medication administration deemed exclusionary by the study investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centre for Neuro Skills
Bakersfield, California, 93313
About this study
The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.
Read the detailed description
The investigators will study subjects (aged 18-70 years) with a history of moderate/severe traumatic brain injury (n=10) and healthy controls (aged 18-70 years) (n=10). All subjects will undergo a 3-month intervention of oral inulin treatment. The traumatic brain injury subjects will be administered oral inulin twice daily for 3 months. Testing including cognitive function assessment (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and questionnaires of fatigue, mood and quality of life and sleep will occur at month 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. In addition, fecal samples for analysis of the GI microbiome will be collected at month -1, month 0, month 1, month 2, month 3, and month 6 along with an assessment of gastrointestinal health. Traumatic brain injury subjects will be selected from residents at a long term residential rehabilitation center. Healthy control subjects will be administered oral inulin twice daily with meals for 3 months. Quality of life will be assessed by questionnaires at months 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. Fecal samples will be collected at month -1, month 0, month 3 and month 6 for analysis of the GI microbiome along with an assessment of gastrointestinal health. A member of the study team will check monthly for adverse events and overall well-being and ensure compliance and ongoing consent.
- Conditions
- Brain Injury, Chronic, Brain Injuries, Traumatic
- Being tested
- Inulin fructooligosaccharide
- Medical subject headings
- Brain Injury, Chronic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin fructooligosaccharideDietary supplement
Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Traumatic Brain Injury | Experimental | Subjects aged 18-70 years with chronic traumatic brain injury receiving Inulin treatment. Receives: Dietary Supplement: Inulin fructooligosaccharide |
| Healthy Controls | Experimental | Healthy subjects aged 18-70 years receiving Inulin treatment. Receives: Dietary Supplement: Inulin fructooligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of fecal microbiome using molecular methods at baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Measured: Baseline
Characterization of fecal microbiome using molecular methods at month 1
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Measured: month 1
Characterization of fecal microbiome using molecular methods at month 2
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Measured: month 2
Characterization of fecal microbiome using molecular methods at month 3
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Measured: month 3
Characterization of fecal microbiome using molecular methods at month 6
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Measured: month 6
Secondary outcomes (108)
Sleep Quality as measured by Pittsburgh Sleep Quality Index at baseline
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality.
Measured: Baseline (month 0)
Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 3
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality.
Measured: month 3
Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 6
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total < 5 associated with good sleep quality. Total > 5 associated with poor sleep quality.
Measured: month 6
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at baseline
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. This assessment is completed by the Traumatic Brain Injury group only.
Measured: Baseline (month 0)
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 3
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. This assessment is completed by the Traumatic Brain Injury group only.
Measured: month 3
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 6
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. This assessment is completed by the Traumatic Brain Injury group only.
Measured: month 6
Depression measured by the Beck Depression Inventory-II at baseline
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Measured: Baseline (month 0)
Depression measured by the Beck Depression Inventory-II at month 3
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Measured: month 3
Depression measured by the Beck Depression Inventory-II at month 6
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Measured: month 6
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Measured: Baseline (month 0)
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 1
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Measured: month 1
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 2
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Measured: month 2
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 3
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Measured: month 3
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 6
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Measured: month 6
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: Baseline (month 0)
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: month 3
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: month 6
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: Baseline (month 0)
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: month 3
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: month 6
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: Baseline (month 0)
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: month 3
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Measured: month 6
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at baseline
The Repeatable Battery Assessment for Neuropsychological Status (RBANS) is a cognitive battery that has been utilized among Traumatic Brain Injury patients. It is comprised of 12 tests that assess five cognitive domains including immediate and delayed memory, language, visuospatial/constructional abilities, and attention. Immediate memory is assessed by two tests (list learning and story learning), visuospatial/constructional abilities is assessed by two tests (figure copy and line orientation), language is assessed by two tests (picture naming and semantic fluency), attention is two tests (digit span and coding), and delayed memory is assessed by four tests (list recall, list recognition, story recall and figure recall). RBANS raw subtests scores are converted to index standard scores. The RBANS has a mean score of 100 with a Standard Deviation of 15. Scores range from 40 to 160. Only the Traumatic Brain Injury group will undergo cognitive assessment.
Measured: Baseline
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 3
The Repeatable Battery Assessment for Neuropsychological Status (RBANS) is a cognitive battery that has been utilized among Traumatic Brain Injury patients. It is comprised of 12 tests that assess five cognitive domains including immediate and delayed memory, language, visuospatial/constructional abilities, and attention. Immediate memory is assessed by two tests (list learning and story learning), visuospatial/constructional abilities is assessed by two tests (figure copy and line orientation), language is assessed by two tests (picture naming and semantic fluency), attention is two tests (digit span and coding), and delayed memory is assessed by four tests (list recall, list recognition, story recall and figure recall). RBANS raw subtests scores are converted to index standard scores. The RBANS has a mean score of 100 with a Standard Deviation of 15. Scores range from 40 to 160. Only the Traumatic Brain Injury group will undergo cognitive assessment.
Measured: month 3
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 6
The Repeatable Battery Assessment for Neuropsychological Status (RBANS) is a cognitive battery that has been utilized among Traumatic Brain Injury patients. It is comprised of 12 tests that assess five cognitive domains including immediate and delayed memory, language, visuospatial/constructional abilities, and attention. Immediate memory is assessed by two tests (list learning and story learning), visuospatial/constructional abilities is assessed by two tests (figure copy and line orientation), language is assessed by two tests (picture naming and semantic fluency), attention is two tests (digit span and coding), and delayed memory is assessed by four tests (list recall, list recognition, story recall and figure recall). RBANS raw subtests scores are converted to index standard scores. The RBANS has a mean score of 100 with a Standard Deviation of 15. Scores range from 40 to 160. Only the Traumatic Brain Injury group will undergo cognitive assessment.
Measured: month 6
1 methyl Histidine at baseline
Amino acid 1 methyl histidine (1MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
1 methyl Histidine at month 3
Amino acid 1 methyl histidine (1MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
3 methyl Histidine at baseline
Amino acid 3 methyl histidine (3MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
3 methyl Histidine at month 3
Amino acid 3 methyl histidine (3MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
L-alpha-Aminoadipic acid at baseline
Amino acid L-alpha-Aminoadipic (Aad) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
L-alpha-Aminoadipic acid at month 3
Amino acid L-alpha-Aminoadipic (Aad) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
2-Aminobutyric Acid at baseline
Amino acid 2-Aminobutyric Acid (Abu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
2-Aminobutyric Acid at month 3
Amino acid 2-Aminobutyric Acid (Abu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Alanine at baseline
Amino acid Alanine (Ala) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Alanine at month 3
Amino acid Asparagine (Asn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Asparagine at baseline
Amino acid Asparagine (Asn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Asparagine at baseline
Amino acid Asparagine (Asn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Arginine at baseline
Amino acid Arginine (Arg) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Arginine at month 3
Amino acid Arginine (Arg) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Aspartate at baseline
Amino acid Aspartate(Asp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Aspartate at month 3
Amino acid Aspartate(Asp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
D, L-beta-Aminoisobutyric acid
Amino acid D, L-beta-Aminoisobutyric acid (bAid) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
D, L-beta-Aminoisobutyric acid
Amino acid D, L-beta-Aminoisobutyric acid (bAid) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
beta-Alanine at baseline
Amino acid beta-Alanine (bAla) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
beta-Alanine at month 3
Amino acid beta-Alanine (bAla) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
L-Carnosine
Amino acid L-Carnosine (Car) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
L-Carnosine
Amino acid L-Carnosine (Car) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Citrulline at baseline
Amino acid citrulline (Cit) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Citrulline at month 3
Amino acid citrulline (Cit) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Cystathionine
Amino acid Cystathionine (Cth) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Cystathionine
Amino acid Cystathionine (Cth) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Cysteine at baseline
Amino acid cysteine (Cys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Cysteine at month 3
Amino acid cysteine (Cys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Ethanolamine at baseline
Amino acid ethanolamine (Etn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Ethanolamine at month 3
Amino acid ethanolamine (Etn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Gamma aminobutyric acid at baseline
Amino acid gamma aminobutyric acid (GABA) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Gamma aminobutyric acid at month 3
Amino acid gamma aminobutyric acid (GABA) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Glutamine at baseline
Amino acid glutamine (Gln) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Glutamine at month 3
Amino acid glutamine (Gln) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Glutamate at baseline
Amino acid glutamate (Glu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Glutamate at month 3
Amino acid glutamate (Glu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Glycine at baseline
Amino acid glycine (Gly) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Glycine at month 3
Amino acid glycine (Gly) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Homocysteine at baseline
Amino acid homocysteine (Hcy) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Homocysteine at month 3
Amino acid homocysteine (Hcy) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Histidine at baseline
Amino acid histidine (His) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Histidine at month 3
Amino acid histidine (His) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Hydroxylysine at baseline
Amino acid hydroxylysine (Hyl) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Hydroxylysine at month 3
Amino acid hydroxylysine (Hyl) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Hydroxyproline at baseline
Amino acid hydroxyproline (Hyp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Hydroxyproline at month 3
Amino acid hydroxyproline (Hyp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Isoleucine at baseline
Amino acid Isoleucine (Ile) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Isoleucine at month 3
Amino acid Isoleucine (Ile) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Leucine at baseline
Amino acid Leucine (Leu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Leucine at month 3
Amino acid Leucine (Leu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Lysine at baseline
Amino acid Lysine (Lys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Lysine at month 3
Amino acid Lysine (Lys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Methionine at baseline
Amino acid Methionine (Met) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Methionine at month 3
Amino acid Methionine (Met) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Norleucine at baseline
Amino acid Norleucine (Nle) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Norleucine at month 3
Amino acid Norleucine (Nle) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Norvaline at baseline
Amino acid Norvaline (Nva) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Norvaline at month 3
Amino acid Norvaline (Nva) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Ornithine at baseline
Amino acid Ornithine (Orn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Ornithine at month 3
Amino acid Ornithine (Orn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
phospho-ethanolamine at baseline
Amino acid phosphoethanolamine (pEtn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
phospho-ethanolamine at month 3
Amino acid phosphoethanolamine (pEtn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Phenylalanine at baseline
Amino acid phenylalanine (Phe) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Phenylalanine at month 3
Amino acid phenylalanine (Phe) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Proline at baseline
Amino acid proline (Pro) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Proline at month 3
Amino acid proline (Pro) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
phospho-serine at baseline
Amino acid phospho-serine (pSer) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
phospho-serine at month 3
Amino acid phospho-serine (pSer) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Sarcosine at baseline
Amino acid sarcosine (Sar) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Sarcosine at month 3
Amino acid sarcosine (Sar) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Serine at baseline
Amino acid serine (Ser) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Serine at month 3
Amino acid serine (Ser) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Taurine at baseline
Amino acid taurine (Tau) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Taurine at month 3
Amino acid taurine (Tau) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Threonine at baseline
Amino acid threonine (Thr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Threonine at month 3
Amino acid threonine (Thr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Tryptophan at baseline
Amino acid tryptophan (Trp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Tryptophan at month 3
Amino acid tryptophan (Trp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Tyrosine at baseline
Amino acid tyrosine (Tyr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Tyrosine at month 3
Amino acid tyrosine (Tyr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Valine at baseline
Amino acid valine (val) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: Baseline (month 0)
Valine at month 3
Amino acid valine (val) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start28 Jul 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be administered 1-4 grams of Inulin twice daily for 3 months.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Neuro Skills
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Brent Masel, MD, Principal investigator, Centre for Neuro Skills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949607
- Sponsor's protocol ID
- Pro00054911
- Status last verified
- Jul 2022
- First submitted
- 25 Jun 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Brain Injury and the Gut Microbiome
- ClinicalTrials.gov ID
- NCT04949607
- Acronym / sponsor ID
- Pro00054911
- Conditions
- Brain Injury, Chronic, Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Centre for Neuro SkillsIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.
Detailed description
The investigators will study subjects (aged 18-70 years) with a history of moderate/severe traumatic brain injury (n=10) and healthy controls (aged 18-70 years) (n=10). All subjects will undergo a 3-month intervention of oral inulin treatment. The traumatic brain injury subjects will be administered oral inulin twice daily for 3 months. Testing including cognitive function assessment (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and questionnaires of fatigue, mood and quality of life and sleep will occur at month 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. In addition, fecal samples for analysis of the GI microbiome will be collected at month -1, month 0, month 1, month 2, month 3, and month 6 along with an assessment of gastrointestinal health. Traumatic brain injury subjects will be selected from residents at a long term residential rehabilitation center. Healthy control subjects will be administered oral inulin twice daily with meals for 3 months. Quality of life will be assessed by questionnaires at months 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. Fecal samples will be collected at month -1, month 0, month 3 and month 6 for analysis of the GI microbiome along with an assessment of gastrointestinal health. A member of the study team will check monthly for adverse events and overall well-being and ensure compliance and ongoing consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be administered 1-4 grams of Inulin twice daily for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Chronic Traumatic Brain Injury | Experimental | Dietary Supplement: Inulin fructooligosaccharideSubjects aged 18-70 years with chronic traumatic brain injury receiving Inulin treatment. |
| Healthy Controls | Experimental | Dietary Supplement: Inulin fructooligosaccharideHealthy subjects aged 18-70 years receiving Inulin treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -Traumatic Brain Injury
- Loss of consciousness
- Post-traumatic amnesia
- Focal neurologic deficits
- Seizures
Key exclusion criteria (9 listed)
- Traumatic Brain Injury
- Healthy Control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin fructooligosaccharideSubjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week. | Dietary supplement | Chronic Traumatic Brain Injury, Healthy Controls |
Primary outcome
Characterization of fecal microbiome using molecular methods at baseline
Time frame: Baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 1
Time frame: month 1
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 2
Time frame: month 2
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 3
Time frame: month 3
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Characterization of fecal microbiome using molecular methods at month 6
Time frame: month 6
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
108 secondary outcomes
Sleep Quality as measured by Pittsburgh Sleep Quality Index at baseline
Time frame: Baseline (month 0)
Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 3
Time frame: month 3
Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 6
Time frame: month 6
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at baseline
Time frame: Baseline (month 0)
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 3
Time frame: month 3
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 6
Time frame: month 6
Depression measured by the Beck Depression Inventory-II at baseline
Time frame: Baseline (month 0)
Depression measured by the Beck Depression Inventory-II at month 3
Time frame: month 3
Depression measured by the Beck Depression Inventory-II at month 6
Time frame: month 6
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
Time frame: Baseline (month 0)
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 1
Time frame: month 1
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 2
Time frame: month 2
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 3
Time frame: month 3
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 6
Time frame: month 6
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Time frame: Baseline (month 0)
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Time frame: month 3
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Time frame: month 6
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Time frame: Baseline (month 0)
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Time frame: month 3
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Time frame: month 6
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Time frame: Baseline (month 0)
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Time frame: month 3
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Time frame: month 6
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at baseline
Time frame: Baseline
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 3
Time frame: month 3
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 6
Time frame: month 6
1 methyl Histidine at baseline
Time frame: Baseline (month 0)
1 methyl Histidine at month 3
Time frame: month 3
3 methyl Histidine at baseline
Time frame: Baseline (month 0)
3 methyl Histidine at month 3
Time frame: month 3
L-alpha-Aminoadipic acid at baseline
Time frame: Baseline (month 0)
L-alpha-Aminoadipic acid at month 3
Time frame: month 3
2-Aminobutyric Acid at baseline
Time frame: Baseline (month 0)
2-Aminobutyric Acid at month 3
Time frame: month 3
Alanine at baseline
Time frame: Baseline (month 0)
Alanine at month 3
Time frame: month 3
Asparagine at baseline
Time frame: Baseline (month 0)
Asparagine at baseline
Time frame: month 3
Arginine at baseline
Time frame: Baseline (month 0)
Arginine at month 3
Time frame: month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent Masel, MD principal investigator
Centre for Neuro Skills
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin fructooligosaccharide in people with Brain Injury, Chronic and Brain Injuries, Traumatic, run by Centre for Neuro Skills at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of fecal microbiome using molecular methods at baseline (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.