Gastrointestinal Disease SymptomsSYNNCT06834984
Ritual Synbiotic+, a Dietary Supplement Designed to Impact Gastrointestinal Health, Mood, and Behavior in Women
A study testing Prebiotic, probiotic, postbiotic combination in people with Gastrointestinal Disease Symptoms, run by Colorado State University at 1 site in United States.
Trial summary
The aim of this study is to determine how regular consumption of Synbiotic+, a dietary supplement that contains prebiotics, probiotics, and postbiotics, impacts functional gastrointestinal health, markers of intestinal inflammation and immune health, and influences mood and behavior. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Gastrointestinal Disease Symptoms
- What is being tested?
- Prebiotic, probiotic, postbiotic combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 3 Sep 2026
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult women (age 25-65, with target average age of 50).
- BMI <30.
- with moderate gastrointestinal symptoms.
- Participants should be willing to follow the study protocol and attend clinic visits.
Who cannot join
- less than 25 years of age or greater than 65 years of age.
- have a BMI >30.
- taken antibiotics within two months or any probiotic supplements within the past 14 days prior to the start of treatment.
- current medications and dietary supplements will be assessed on a case-by- case basis and will result in exclusion if there is the possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, NSAIDs, MAO inhibitors, and hormone therapies.
- Individuals with current disease diagnosis, including diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)
- pregnant and breastfeeding people.
- overuse of alcohol as determined on a case-by-case self-reported alcohol use.
- if the individual feels they are unable to adhere to the study requirements, which includes consuming capsules, providing stool or blood samples, tracking bowel movements and symptoms, and attending scheduled clinic visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University Food and Nutrition Clinical Research Laboratory
Fort Collins, Colorado, 80523
About this study
Official title: Ritual Synbiotic+, a Dietary Supplement
The aim of this study is to determine how regular consumption of Synbiotic+, a dietary supplement that contains prebiotics, probiotics, and postbiotics, impacts functional gastrointestinal health, markers of intestinal inflammation and immune health, and influences mood and behavior. The primary outcome will be to assess gastrointestinal health using bowel movement tracking, self-report and objective assessments of gastrointestinal symptom severity, stool levels of short chain fatty acids, changes in the gut microbiota, including recovery of LGG and BB-12, and functional measures of the microbiome. Secondary outcomes will include stool and blood markers of gut barrier function and intestinal inflammation, immune health, and self-assessments of stress, anxiety, sleep, and quality of life.
Read the detailed description
The trial will be a double-blinded, randomized, placebo-controlled parallel arm intervention study taking place at Colorado State University. In total, ~100 adult women (25-65 years old) with a BMI <30, with moderate digestive discomfort (as evidenced by a moderate score on a functional gastrointestinal questionnaire will be enrolled into the study. With an estimated 20% attrition rate, this will allow approximately 80 individuals to complete the study. Exclusion criteria include a BMI>30, any significant systemic diseases (including Crohn's, Ulcerative Colitis, but not including diagnosis of Irritable Bowel Syndrome), prescription medication for digestive symptoms, antibiotic or probiotic ingestion within the two months before entry into the study, and pregnancy or breastfeeding. Subjects will be provided with the consent form prior to the baseline visit and informed consent will be obtained prior to participating in the study. Participants will be compensated for their participation. Medical health history will be collected at the baseline visit. Quality of Life (QOL) and GI Health questionnaires, along with questionnaires to gauge mood and anxiety, will be collected from each enrolled participant at the baseline, mid-point ("check-in visit 2"), and final clinic visits; a GI health questionnaire will also be collected at the acute study visit (48-72 hours after treatment start). Anthropometric measures at the baseline visit will include seated blood pressure, height, weight, and waist:hip measurements; blood pressure will also be collected at the final visit. A stool sample will be collected from participants at each clinic visit, and a blood sample will be collected at the baseline and final clinical visits. Two 3-day diet records will be completed prior to the start and at completion of the study. In addition, participants will keep a daily record of their bowel movements and brief notes regarding any GI symptoms starting 7-days prior to beginning the treatment and for the duration of the study.
All enrolled participants will start with a baseline clinic visit and a 7-day lead in period, after which they will take one of the treatments for 12 weeks. To determine the acute effects of the treatment, participants will return a stool sample to the clinic 48-72 hours after the treatment start to establish acute effects (ie. changes in SCFA, microbial dysbiosis index). Subjects will randomly be assigned to a starting treatment (A or B) and capsules will be blinded and labeled by Ritual personnel who are not directly involved in the study. CSU clinical personnel will not be provided with the code for treatment groups until after all data analysis has been completed.
- Conditions
- Gastrointestinal Disease Symptoms
- Being tested
- Prebiotic, probiotic, postbiotic combination, Placebo
- Keywords
- Women with gastrointestinal symptoms, Probiotic, Prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic, probiotic, postbiotic combinationDietary supplement
The product consists of two probiotics, Lactobacillus rhamnosus LGG and Bifidibacterium animalis subsp. lactis BB-12, supplied at a total concentration of 11B CFU's, a prebiotic consisting of 1 × 106 Plaque Forming Units (PFU) LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae bacteriophages, marketed as PreforPro, and tributyrin- a stale form of butyrate
PlaceboDietary supplement
Placebo pill containing stomach acid-resistant outer vegan capsule (hypromellose, gellan gum), hi oleic safflower oil, inner vegan capsule (hypromellose, gellan gum) microcrystalline cellulose, ascorbyl palmitate, silica
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (probiotic supplement) | Experimental | This group will take a once daily supplement containing pre-pro-post biotics. Receives: Dietary Supplement: Prebiotic, probiotic, postbiotic combination |
| Control | Placebo comparator | This group will be taking a once daily placebo pill. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale
Measures Abdominal Pain Heartburn Acid Regurgitation Sucking Sensations in the Epigastrium Nausea \& Vomiting Borborygmus (rumbling) Abdominal Distension (bloating) Eructation (burping) Flatus (gas) Decreased or Increased Passage of Stools Loose or Hard Stools Urgent Need for Defecation Feeling of Incomplete Evacuation Rated on a scale starting at "No Discomfort at all" to "Very severe discomfort", where better outcomes are associated with "No Discomfort At All" while worse outcomes are associated near(er) to "Very Severe Discomfort".
Measured: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Total number and types of bowel movements
Defecation frequency and proportion of abnormal to normal bowel movements as recorded in a diary using the Bristol Stool Form Scale. The scale runs from 1-7 with healthier outcomes associated with 3-5 on the Bristol scale.
Measured: Daily for 12 weeks
Short Chain Fatty Acid concentration in stool
Gas chromatography will be used to measure changes in SCFA production in stool.
Measured: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Fecal pH
Stool sample pH will be measured before and after treatment.
Measured: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Microbial composition (alpha and beta diversity, dysbiosis index, differential taxa)
Changes in microbiota profiles, ratio of pro-inflammatory to beneficial microbes, recovery of LGG \& BB-12 in stool; measured using 16s rRNA and targeted assays.
Measured: 2X: baseline, and final (12 weeks)
Secondary outcomes (25)
Fecal calprotectin
Intestinal inflammation
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Alpha-1 antitrypsin
Gut permeability
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Lipopolysaccharide binding protein and soluble CD14 in blood
Barrier function: Lipopolysaccharide binding protein and soluble CD14 are involved in binding LPS and initiating systemic inflammatory cascades and have been used as a proxy for gut barrier function.
Measured: 2X: baseline, and final (12 weeks)
Human high sensitivity T-cell panel/Peripheral blood mononuclear cells (PBMCs)
Immune health: in supernatants from LPS-stimulated PBMC; uses Milliplex MAP
Measured: 2X: baseline, and final (12 weeks)
Alpha-1 antitrypsin in blood
Gut permeability/malabsorption
Measured: 2X: baseline, and final (12 weeks)
Cortisol blood levels
Cortisol levels
Measured: 2X: baseline, and final (12 weeks)
GLP-1
GLP-1 levels, metabolic health, measured with ELISA assay.
Measured: 2X: baseline, and final (12 weeks)
Quality of Life as measured by Inflammatory Bowel Disease (IBD) Specific Quality of Life survey
Online Survey measuring Helplessness, Embarrassment, Vulnerability, Discomfort, Enjoyment of Life, Body Image, Depression, Isolation, Behavior Change, Anger, and Irritability in regards to bowel problems.
Survey scale starts at "not at all" and goes up to "extremely" with healthier outcomes associated with "not at all".
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Generalized Anxiety Disorder 7 Item Survey
The GAD-7 (Generalized Anxiety Disorder-7) is a self-report questionnaire designed to screen for generalized anxiety disorder (GAD) and assess the severity of anxiety symptoms in individuals. It consists of 7 questions that focus on the frequency of anxiety-related symptoms experienced over the past two weeks.
Scoring:
0-4: Minimal or no anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15-21: Severe anxiety
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Positive and Negative Affect Schedule
Subjective experience of mood (how you feel on average) rated on a scale from "very slightly or none at all" to "extremely". Moods can be positive (e.g inspiration) or negative (e.g. guilty), so the score does not reflect a better or worse outcome.
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Perceived Stress Scale
Subjective experiences of stress. The questions in this scale ask about your feelings and thoughts during the last month. In each case, you will be asked to indicate how often you felt or thought a certain way. The scale ranges from "never" to "very often". Questions are regarding positive and negative situations, so a total score is not indicative of a better or worse outcome.
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Ritual Marketing Interest measuring the user experience of the probiotic supplement.
Subjective experiences regarding smell, taste, ingestion, tolerability, nausea, burping, after taking the product. Also asks whether the participant would recommend the product, enjoyed the overall experience, easy to incorporate into daily routine, whether it improved skin and/or stomach discomfort.
The survey uses a Likert Scale for all questions. Each question is situational in that the lower score, "Strongly Disagree" or the higher score "Strongly Agree" do not correlate as a "better" or "worse" outcome across all questions.
Measured: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Blood Glucose levels
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, final (12 weeks)
Alanine Aminotransferase (ALT) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Aspartate Aminotransferase (AST) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Alkaline Phosphatase (ALP) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Blood Creatinine
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Blood bilirubin
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Total Cholesterol
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
High Density Lipoprotein (HDL) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Blood Triglycerides
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Non-HDL Cholesterol (nHDLc)
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Total Cholesterol to HDL ratio (TC/H) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Low Density Lipoprotein (LDL) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Very low density lipoprotein (VLDL) in blood
Measured with a point of care instrument (Piccolo Express) using a disc-based photometric analysis.
Measured: 2X: baseline, and final (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 May 2025
- Primary completion1 Aug 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Disease SymptomsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ritual
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834984
- Sponsor's protocol ID
- 6393
- Acronym
- SYN
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2025
- Last updated
- 10 Sep 2026
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ritual Synbiotic+, a Dietary Supplement
- ClinicalTrials.gov ID
- NCT06834984
- Acronym / sponsor ID
- SYN / 6393
- Conditions
- Gastrointestinal Disease Symptoms
- Keywords
- Women with gastrointestinal symptoms, Probiotic, Prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Ritual
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 19 Feb 2025 (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 aim of this study is to determine how regular consumption of Synbiotic+, a dietary supplement that contains prebiotics, probiotics, and postbiotics, impacts functional gastrointestinal health, markers of intestinal inflammation and immune health, and influences mood and behavior. The primary outcome will be to assess gastrointestinal health using bowel movement tracking, self-report and objective assessments of gastrointestinal symptom severity, stool levels of short chain fatty acids, changes in the gut microbiota, including recovery of LGG and BB-12, and functional measures of the microbiome. Secondary outcomes will include stool and blood markers of gut barrier function and intestinal inflammation, immune health, and self-assessments of stress, anxiety, sleep, and quality of life.
Detailed description
The trial will be a double-blinded, randomized, placebo-controlled parallel arm intervention study taking place at Colorado State University. In total, ~100 adult women (25-65 years old) with a BMI <30, with moderate digestive discomfort (as evidenced by a moderate score on a functional gastrointestinal questionnaire will be enrolled into the study. With an estimated 20% attrition rate, this will allow approximately 80 individuals to complete the study. Exclusion criteria include a BMI>30, any significant systemic diseases (including Crohn's, Ulcerative Colitis, but not including diagnosis of Irritable Bowel Syndrome), prescription medication for digestive symptoms, antibiotic or probiotic ingestion within the two months before entry into the study, and pregnancy or breastfeeding. Subjects will be provided with the consent form prior to the baseline visit and informed consent will be obtained prior to participating in the study. Participants will be compensated for their participation. Medical health history will be collected at the baseline visit. Quality of Life (QOL) and GI Health questionnaires, along with questionnaires to gauge mood and anxiety, will be collected from each enrolled participant at the baseline, mid-point ("check-in visit 2"), and final clinic visits; a GI health questionnaire will also be collected at the acute study visit (48-72 hours after treatment start). Anthropometric measures at the baseline visit will include seated blood pressure, height, weight, and waist:hip measurements; blood pressure will also be collected at the final visit. A stool sample will be collected from participants at each clinic visit, and a blood sample will be collected at the baseline and final clinical visits. Two 3-day diet records will be completed prior to the start and at completion of the study. In addition, participants will keep a daily record of their bowel movements and brief notes regarding any GI symptoms starting 7-days prior to beginning the treatment and for the duration of the study.
All enrolled participants will start with a baseline clinic visit and a 7-day lead in period, after which they will take one of the treatments for 12 weeks. To determine the acute effects of the treatment, participants will return a stool sample to the clinic 48-72 hours after the treatment start to establish acute effects (ie. changes in SCFA, microbial dysbiosis index). Subjects will randomly be assigned to a starting treatment (A or B) and capsules will be blinded and labeled by Ritual personnel who are not directly involved in the study. CSU clinical personnel will not be provided with the code for treatment groups until after all data analysis has been completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (probiotic supplement) | Experimental | Dietary Supplement: Prebiotic, probiotic, postbiotic combinationThis group will take a once daily supplement containing pre-pro-post biotics. |
| Control | Placebo comparator | Dietary Supplement: PlaceboThis group will be taking a once daily placebo pill. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adult women (age 25-65, with target average age of 50).
- BMI <30.
- with moderate gastrointestinal symptoms.
- Participants should be willing to follow the study protocol and attend clinic visits.
Key exclusion criteria (8 listed)
- less than 25 years of age or greater than 65 years of age.
- have a BMI >30.
- taken antibiotics within two months or any probiotic supplements within the past 14 days prior to the start of treatment.
- current medications and dietary supplements will be assessed on a case-by- case basis and will result in exclusion if there is the possibility that the drugs or supplements used would influence the endpoints of the study. This would include statins, metformin, NSAIDs, MAO inhibitors, and hormone therapies.
- Individuals with current disease diagnosis, including diagnosis of cancer, liver or kidney disease, gastrointestinal diseases, and cardiometabolic disorders (cardiovascular disease, diabetes, etc.)
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 |
|---|---|---|
| Prebiotic, probiotic, postbiotic combinationThe product consists of two probiotics, Lactobacillus rhamnosus LGG and Bifidibacterium animalis subsp. lactis BB-12, supplied at a total concentration of 11B CFU's, a prebiotic consisting of 1 × 106 Plaque Forming Units (PFU) LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae bacteriophages, marketed as PreforPro, and tributyrin- a stale form of butyrate | Dietary supplement | Treatment Group (probiotic supplement) |
| PlaceboPlacebo pill containing stomach acid-resistant outer vegan capsule (hypromellose, gellan gum), hi oleic safflower oil, inner vegan capsule (hypromellose, gellan gum) microcrystalline cellulose, ascorbyl palmitate, silica | Dietary supplement | Control |
Primary outcome
Gastrointestinal Symptom Rating Scale
Time frame: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Measures Abdominal Pain Heartburn Acid Regurgitation Sucking Sensations in the Epigastrium Nausea \& Vomiting Borborygmus (rumbling) Abdominal Distension (bloating) Eructation (burping) Flatus (gas) Decreased or Increased Passage of Stools Loose or Hard Stools Urgent Need for Defecation Feeling of Incomplete Evacuation Rated on a scale starting at "No Discomfort at all" to "Very severe discomfort", where better outcomes are associated with "No Discomfort At All" while worse outcomes are associated near(er) to "Very Severe Discomfort".
Total number and types of bowel movements
Time frame: Daily for 12 weeks
Defecation frequency and proportion of abnormal to normal bowel movements as recorded in a diary using the Bristol Stool Form Scale. The scale runs from 1-7 with healthier outcomes associated with 3-5 on the Bristol scale.
Short Chain Fatty Acid concentration in stool
Time frame: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Gas chromatography will be used to measure changes in SCFA production in stool.
Fecal pH
Time frame: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).
Stool sample pH will be measured before and after treatment.
Microbial composition (alpha and beta diversity, dysbiosis index, differential taxa)
Time frame: 2X: baseline, and final (12 weeks)
Changes in microbiota profiles, ratio of pro-inflammatory to beneficial microbes, recovery of LGG \& BB-12 in stool; measured using 16s rRNA and targeted assays.
25 secondary outcomes
Fecal calprotectin
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Alpha-1 antitrypsin
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Lipopolysaccharide binding protein and soluble CD14 in blood
Time frame: 2X: baseline, and final (12 weeks)
Human high sensitivity T-cell panel/Peripheral blood mononuclear cells (PBMCs)
Time frame: 2X: baseline, and final (12 weeks)
Alpha-1 antitrypsin in blood
Time frame: 2X: baseline, and final (12 weeks)
Cortisol blood levels
Time frame: 2X: baseline, and final (12 weeks)
GLP-1
Time frame: 2X: baseline, and final (12 weeks)
Quality of Life as measured by Inflammatory Bowel Disease (IBD) Specific Quality of Life survey
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Generalized Anxiety Disorder 7 Item Survey
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Positive and Negative Affect Schedule
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Perceived Stress Scale
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Ritual Marketing Interest measuring the user experience of the probiotic supplement.
Time frame: 3X: baseline, mid-point (6 weeks), final (12 weeks)
Blood Glucose levels
Time frame: 2X: baseline, final (12 weeks)
Alanine Aminotransferase (ALT) in blood
Time frame: 2X: baseline, and final (12 weeks)
Aspartate Aminotransferase (AST) in blood
Time frame: 2X: baseline, and final (12 weeks)
Alkaline Phosphatase (ALP) in blood
Time frame: 2X: baseline, and final (12 weeks)
Blood Creatinine
Time frame: 2X: baseline, and final (12 weeks)
Blood bilirubin
Time frame: 2X: baseline, and final (12 weeks)
Total Cholesterol
Time frame: 2X: baseline, and final (12 weeks)
High Density Lipoprotein (HDL) in blood
Time frame: 2X: baseline, and final (12 weeks)
Blood Triglycerides
Time frame: 2X: baseline, and final (12 weeks)
Non-HDL Cholesterol (nHDLc)
Time frame: 2X: baseline, and final (12 weeks)
Total Cholesterol to HDL ratio (TC/H) in blood
Time frame: 2X: baseline, and final (12 weeks)
Low Density Lipoprotein (LDL) in blood
Time frame: 2X: baseline, and final (12 weeks)
Very low density lipoprotein (VLDL) in blood
Time frame: 2X: baseline, and final (12 weeks)
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 10 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic, probiotic, postbiotic combination in people with Gastrointestinal Disease Symptoms, run by Colorado State University 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 4 inclusion and 8 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 10 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
Gastrointestinal Symptom Rating Scale (time frame: 4X: baseline, acute (3 days), mid-point (6 weeks), final (12 weeks).). 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 10 Sep 2026.