Spinal Cord InjuriesNCT05670288
Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
An observational study of Spinal Cord Injuries and Gut Microbiome, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline [within 6 weeks of injury], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spinal Cord Injuries, Gut Microbiome
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had an acute spinal cord injury in the past 6 weeks.
Who may be able to join
- 18-85 years of age
- diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
- classification of A, B, C (motor complete, incomplete).
Who cannot join
- Women who are pregnant prior to consent
- neurological impairment other than SCI
- self-reported history of Crohn's disease or diverticulitis
- irritable bowel syndrome
- gastric blockage/obstruction or swallowing disorder
- prior GI surgery
Show all 9Show fewer
- intrathecal pump
- concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).
- able to ambulate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama at Birmingahm
Birmingham, Alabama, 35294
Jereme Wilroy, PhD, (205) 934-0355, jdwilroy@uab.edu
Jereme Wilroy, PhD
About this study
The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline [within 6 weeks of injury], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.
Read the detailed description
Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.
For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage.
The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab
For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements [CDEs], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 [PHQ9] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction
- Conditions
- Spinal Cord Injuries, Gut Microbiome
- Keywords
- SCI, Inflammation, Bowel Function, Blood Sugar, Lipid Profiles
- Medical subject headings
- Spinal Cord Injuries, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | Patients who have had an acute spinal cord injury in the past 72 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Measured: Baseline
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Measured: Baseline
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Measured: Baseline
Neurological impairment - completeness of injury by AIS
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Measured: Baseline
Neurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Measured: Month 6
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Measured: Month 6
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Measured: Month 6
Neurological impairment - completeness of injury by AIS
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Measured: Month 6
Neurological impairment - Injury level by ISNCSCI
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Measured: Month 12
Neurological impairment - Injury level by AIS
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Measured: Month 12
Neurological impairment - completeness of injury by ISNCSCI
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Measured: Month 12
Neurological impairment - completeness of injury by AIS
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Measured: Month 12
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Measured: Baseline
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Measured: Month 1
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Measured: Month 6
Microbiome composition - Bacterial 16S rRNA sequincing
Bacterial 16S rRNA sequencing will be performed
Measured: Month 12
Microbiome composition - Metagenomics
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Measured: Baseline
Microbiome composition - Metagenomics
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Measured: Month 1
Microbiome composition - Metagenomics
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Measured: Month 6
Microbiome composition - Metagenomics
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Measured: Month 12
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Measured: Baseline
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Measured: Month 1
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Measured: Month 6
Gut derived metabolites
Blood will be collected and serum extract metabolites will be isolated
Measured: Month 12
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Measured: Baseline
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Measured: Month 1
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Measured: Month 6
Analysis of metabolic markers to determine metabolic function
Blood will be collected and serum assays for metabolic markers performed
Measured: Month 12
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Measured: Baseline
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Measured: Month 1
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Measured: Month 6
Analysis of inflammatory markers to determine Inflammatory state
Blood will be collected and serum assays for inflammatory markers performed
Measured: Month 12
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Measured: Baseline
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Measured: Baseline
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Measured: Month 1
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Measured: Month 1
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Measured: Month 6
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Measured: Month 6
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Measured: Month 12
Bowel function - Bristol Stool Scale
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Measured: Month 12
Secondary outcomes (40)
Diet
Participant records 24-hour dietary recalls
Measured: Baseline
Diet
Participant records 24-hour dietary recalls
Measured: Month 1
Diet
Participant records 24-hour dietary recalls
Measured: Month 6
Diet
Participant records 24-hour dietary recalls
Measured: Month 12
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Measured: Baseline
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Measured: Baseline
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Measured: Month 1
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Measured: Month 1
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Measured: Month 6
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Measured: Month 6
Physical activity - PARA-SCI
Complete PARA-SCI questionnaire to determine physical activity level
Measured: Month 12
Physical activity - CDEs
Complete rehabilitation therapies survey (CDEs) to determine physical activity level
Measured: Month 12
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Measured: Baseline
Medication List - Self-report
Self-report of prescribed medications being taken
Measured: Baseline
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Measured: Month 1
Medication List - Self-report
Self-report of prescribed medications being taken
Measured: Month 1
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Measured: Month 6
Medication List - Self-report
Self-report of prescribed medications being taken
Measured: Month 6
Medication List - Medical Record Review
Medical record review of prescribed medications being taken
Measured: Month 12
Medication List - Self-report
Self-report of prescribed medications being taken
Measured: Month 12
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Measured: Baseline
Supplement usage - self-report
Self-report of supplements being taken
Measured: Baseline
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Measured: Month 1
Supplement usage - self-report
Self-report of supplements being taken
Measured: Month 1
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Measured: Month 6
Supplement usage - self-report
Self-report of supplements being taken
Measured: Month 6
Supplement usage - Medical Record Review
Medical record review of supplements being taken
Measured: Month 12
Supplement usage - self-report
Self-report of supplements being taken
Measured: Month 12
Depression
Complete PHQ9 questionnaires to determine depression level
Measured: Baseline
Depression
Complete PHQ9 questionnaires to determine depression level
Measured: Month 1
Depression
Complete PHQ9 questionnaires to determine depression level
Measured: Month 6
Depression
Complete PHQ9 questionnaires to determine depression level
Measured: Month 12
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Measured: Baseline
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Measured: Month 1
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Measured: Month 6
Anxiety
Complete GAD7 questionnaire to determine anxiety level
Measured: Month 12
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Measured: Baseline
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Measured: Month 1
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Measured: Month 6
Comorbidities
Evaluate Medical history (CDEs) for any other comorbidities beyond GI dysfunction
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start15 Oct 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Craig Hospital, Rancho Los Amigos National Rehabilitation Center
- Responsible party
- Principal investigator, Jereme Wilroy, University of Alabama at Birmingham
- Investigators
- Jereme Wilroy, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670288
- Sponsor's protocol ID
- IRB-300010011
- Other IDs
- 90SIMS0020
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2022
- Last updated
- 17 Dec 2025
- 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 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05670288
- Acronym / sponsor ID
- IRB-300010011
- Conditions
- Spinal Cord Injuries, Gut Microbiome
- Keywords
- SCI, Inflammation, Bowel Function, Blood Sugar, Lipid Profiles
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center, Craig Hospital, Rancho Los Amigos National Rehabilitation Center
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 4 Jan 2023 (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 Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline [within 6 weeks of injury], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.
Detailed description
Stool and fasting blood collection will occur at the rehabilitation hospital (during in-patient stay) and at participants' homes. During the hospital stay, stool will be collected at the bedside by the research team and placed in a Para-pak® vial for sample preservation. Blood will also be collected by the research team.
For sample collection at home, a research nurse will travel to participants home to perform blood draws and bing back to the research lab for processing/analysis/storage.
The nurse may also collect the stool sample at the same time as the blood draw if available. If not, participants and their caregivers will be provided with a pre-paid/labeled FedEx package containing a stool collection kit (Para-pak® vial). Prior to bowel movement, participants and caregivers will be asked to clean the anal area using the sanitizing wipes; approximately 5-10 mL of stool will be transferred to the Para-pak® vial using the attached spatula in the Para-pak® vial. For participants who conduct their bowel management program in their beds, an additional sterile absorbent pad will be provided to use as a barrier between the bed and the participant to limit contamination. FedEx package containing the stool sample will be shipped to the investigators' lab
For each participant, the Investigators will record 1) diet (via 24-hour dietary recalls), 2) physical activity habits (via the rehabilitation therapies survey included in the SCI common data elements [CDEs], 3)Leisure Time Physical Activity Questionnaire; 4)depression and anxiety (via Patient Health Questionnaire-9 [PHQ9] and the General Anxiety Disorder-7 scale (GAD7),respectively); 5)prescribed medications, including antibiotics (via RedCap platform); 6)use of supplements and bowel routine components, including probiotics and laxatives (via self-report); and 7)any other comorbidities beyond GI dysfunction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | –Patients who have had an acute spinal cord injury in the past 72 hours |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had an acute spinal cord injury in the past 6 weeks.
Key inclusion criteria (3 listed)
- 18-85 years of age
- diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)
- classification of A, B, C (motor complete, incomplete).
Key exclusion criteria (9 listed)
- Women who are pregnant prior to consent
- neurological impairment other than SCI
- self-reported history of Crohn's disease or diverticulitis
- irritable bowel syndrome
- gastric blockage/obstruction or swallowing disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurological impairment - Injury level by ISNCSCI
Time frame: Baseline
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Neurological impairment - Injury level by AIS
Time frame: Baseline
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Neurological impairment - completeness of injury by ISNCSCI
Time frame: Baseline
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Neurological impairment - completeness of injury by AIS
Time frame: Baseline
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Neurological impairment - Injury level by ISNCSCI
Time frame: Month 6
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Neurological impairment - Injury level by AIS
Time frame: Month 6
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Neurological impairment - completeness of injury by ISNCSCI
Time frame: Month 6
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Neurological impairment - completeness of injury by AIS
Time frame: Month 6
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Neurological impairment - Injury level by ISNCSCI
Time frame: Month 12
Injury level determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Neurological impairment - Injury level by AIS
Time frame: Month 12
Injury level determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Neurological impairment - completeness of injury by ISNCSCI
Time frame: Month 12
Completeness of injury determined by International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
Neurological impairment - completeness of injury by AIS
Time frame: Month 12
Completeness of injury determined by American Spinal Injury Association Impairment Scale (AIS). classification.
Microbiome composition - Bacterial 16S rRNA sequincing
Time frame: Baseline
Bacterial 16S rRNA sequencing will be performed
Microbiome composition - Bacterial 16S rRNA sequincing
Time frame: Month 1
Bacterial 16S rRNA sequencing will be performed
Microbiome composition - Bacterial 16S rRNA sequincing
Time frame: Month 6
Bacterial 16S rRNA sequencing will be performed
Microbiome composition - Bacterial 16S rRNA sequincing
Time frame: Month 12
Bacterial 16S rRNA sequencing will be performed
Microbiome composition - Metagenomics
Time frame: Baseline
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Microbiome composition - Metagenomics
Time frame: Month 1
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Microbiome composition - Metagenomics
Time frame: Month 6
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Microbiome composition - Metagenomics
Time frame: Month 12
A subset of 16S rRNA gene surveys that show differences in taxa and alpha and beta diversity are selected for follow-up via shotgun metagenomics.
Gut derived metabolites
Time frame: Baseline
Blood will be collected and serum extract metabolites will be isolated
Gut derived metabolites
Time frame: Month 1
Blood will be collected and serum extract metabolites will be isolated
Gut derived metabolites
Time frame: Month 6
Blood will be collected and serum extract metabolites will be isolated
Gut derived metabolites
Time frame: Month 12
Blood will be collected and serum extract metabolites will be isolated
Analysis of metabolic markers to determine metabolic function
Time frame: Baseline
Blood will be collected and serum assays for metabolic markers performed
Analysis of metabolic markers to determine metabolic function
Time frame: Month 1
Blood will be collected and serum assays for metabolic markers performed
Analysis of metabolic markers to determine metabolic function
Time frame: Month 6
Blood will be collected and serum assays for metabolic markers performed
Analysis of metabolic markers to determine metabolic function
Time frame: Month 12
Blood will be collected and serum assays for metabolic markers performed
Analysis of inflammatory markers to determine Inflammatory state
Time frame: Baseline
Blood will be collected and serum assays for inflammatory markers performed
Analysis of inflammatory markers to determine Inflammatory state
Time frame: Month 1
Blood will be collected and serum assays for inflammatory markers performed
Analysis of inflammatory markers to determine Inflammatory state
Time frame: Month 6
Blood will be collected and serum assays for inflammatory markers performed
Analysis of inflammatory markers to determine Inflammatory state
Time frame: Month 12
Blood will be collected and serum assays for inflammatory markers performed
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
Time frame: Baseline
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Bowel function - Bristol Stool Scale
Time frame: Baseline
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
Time frame: Month 1
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Bowel function - Bristol Stool Scale
Time frame: Month 1
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
Time frame: Month 6
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Bowel function - Bristol Stool Scale
Time frame: Month 6
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
Bowel function - International Bowel Function Basic and Extended Data Set Assessment
Time frame: Month 12
International Bowel Function Basic and Extended Data Set assessment will be utilized to assess bowel-related symptoms.
Bowel function - Bristol Stool Scale
Time frame: Month 12
Bristol Stool Scale assessment will be utilized to assess bowel-related symptoms.
40 secondary outcomes
Diet
Time frame: Baseline
Diet
Time frame: Month 1
Diet
Time frame: Month 6
Diet
Time frame: Month 12
Physical activity - PARA-SCI
Time frame: Baseline
Physical activity - CDEs
Time frame: Baseline
Physical activity - PARA-SCI
Time frame: Month 1
Physical activity - CDEs
Time frame: Month 1
Physical activity - PARA-SCI
Time frame: Month 6
Physical activity - CDEs
Time frame: Month 6
Physical activity - PARA-SCI
Time frame: Month 12
Physical activity - CDEs
Time frame: Month 12
Medication List - Medical Record Review
Time frame: Baseline
Medication List - Self-report
Time frame: Baseline
Medication List - Medical Record Review
Time frame: Month 1
Medication List - Self-report
Time frame: Month 1
Medication List - Medical Record Review
Time frame: Month 6
Medication List - Self-report
Time frame: Month 6
Medication List - Medical Record Review
Time frame: Month 12
Medication List - Self-report
Time frame: Month 12
Supplement usage - Medical Record Review
Time frame: Baseline
Supplement usage - self-report
Time frame: Baseline
Supplement usage - Medical Record Review
Time frame: Month 1
Supplement usage - self-report
Time frame: Month 1
Supplement usage - Medical Record Review
Time frame: Month 6
Supplement usage - self-report
Time frame: Month 6
Supplement usage - Medical Record Review
Time frame: Month 12
Supplement usage - self-report
Time frame: Month 12
Depression
Time frame: Baseline
Depression
Time frame: Month 1
Depression
Time frame: Month 6
Depression
Time frame: Month 12
Anxiety
Time frame: Baseline
Anxiety
Time frame: Month 1
Anxiety
Time frame: Month 6
Anxiety
Time frame: Month 12
Comorbidities
Time frame: Baseline
Comorbidities
Time frame: Month 1
Comorbidities
Time frame: Month 6
Comorbidities
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- 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.
Jereme Wilroy, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Gut Microbiome, run by University of Alabama at Birmingham 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 3 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: looking for participants now, as of the sponsor's last update on 17 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jereme Wilroy, PhD ((205) 934-0355, jdwilroy@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological impairment - Injury level by ISNCSCI (time frame: Baseline). The study lists 40 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 17 Dec 2025.