Spinal Cord InjuryNCT07640152
Fermented Foods and Bowel Health in SCI
A study testing fermented foods and Sitz Marker Test in people with Spinal Cord Injury, run by Ohio State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- fermented foods and Sitz Marker Test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Jul 2029
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years
- At least 1 year post-onset of spinal cord injury, consistent with chronic spinal cord injury
- Traumatic spinal cord injury involving cervical or thoracic levels
- American Spinal Injury Association Impairment Scale classification A-D
- Medically stable, with no recent hospitalizations or acute illnesses
- Able to safely consume study foods, including fermented and control food products
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- Experiencing neurogenic bowel dysfunction, defined by at least one of the following:
- Three or fewer bowel movements per week
- More than 60 minutes required per bowel care routine
- Symptoms of incomplete evacuation
- Abdominal distension
- Fecal incontinence
- Established and stable bowel program, defined as a consistent individualized routine of timing, frequency, and evacuation methods that has remained unchanged for at least 4 weeks before enrollment
Who cannot join
- Antibiotic use within the past 4 weeks
- Active gastrointestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal obstruction
- Current intake of probiotics or fermented foods exceeding 3 servings per day
- Pregnancy or breastfeeding
- Recent major bowel surgery within the past 12 weeks
- Unresolved fecal impaction
Show all 11Show fewer
- Unstable bowel regimen that could interfere with accurate motility assessment
- Inability to safely undergo Sitz marker testing, including any of the following:
- Inability to swallow the capsule
- Pregnancy, due to radiation exposure
- Contraindication to abdominal X-ray procedures
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
Ohio State University
Columbus, Ohio, 43210
Jia Li Li, PhD, 6146889094, jia.li@osumc.edu
About this study
Official title: High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI
The goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are:
- Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI?
- Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation?
Read more
Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes.
Participants will:
- Consume study foods daily for 10 weeks
- Attend 2 in-person study visits
- Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials
- Complete bowel health questionnaires and dietary recalls
- Undergo Sitz marker testing with abdominal X-rays to assess colonic transit
- Participate in biweekly monitoring contacts throughout the study period
- Conditions
- Spinal Cord Injury
- Being tested
- fermented foods, Control diet, Sitz Marker Test
- Keywords
- gut microbiome, bowel dysfunction, fermented food
- Medical subject headings
- Spinal Cord Injuries, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented foodsOther
Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.
Control dietOther
Participants randomized to the control arm will receive non-fermented versions of the base foods consumed by the fermented food arm and will be instructed to avoid fermented foods during the trial.
Sitz Marker TestDevice
Colonic transit time will be assessed using the Sitz marker test, a standardized radiopaque marker method for evaluating bowel motility. Participants will swallow a capsule containing radiopaque markers, and abdominal X-rays will be obtained on day 5 to determine the number and distribution of retained markers throughout the colon. Greater marker retention indicates slower colonic transit, whereas fewer retained markers indicate faster transit and improved bowel motility.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Food Arm | Experimental | Fermented food arm: participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance. A 3-week ramp-up (weeks 1-3) will increase intake from 2 to 6 servings/day, followed by a 7-week full-intake phase (weeks 4-10). To avoid single-food dominance and improve microbiome diversity, participants will be required to consume ≥3 categories/day (e.g., vegetables, dairy, soy, tea, brine) and rotate through all core fermented food categories and consume a variety of items across a 2-3-day period. This will ensure all core items are consumed throughout the week. Core food items will be delivered biweekly. Receives: Other: fermented foods; Device: Sitz Marker Test |
| Control Diet Arm | Placebo comparator | Participants randomized to the control arm will receive non-fermented versions of the base foods consumed by the fermented foods arm and will be instructed to avoid fermented foods during the trial. Receives: Other: Control diet; Device: Sitz Marker Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiome composition assessed by shotgun metagenomic sequencing
Stool samples will be analyzed using shotgun metagenomic sequencing to characterize gut microbial taxonomic composition. Outcomes may include relative abundance of bacterial taxa and alpha/beta diversity metrics.
Measured: Baseline, weeks 5 and 10
Gut microbiome functional potential measured by shotgun metagenomic sequencing
Shotgun metagenomic sequencing data will be used to assess microbial functional potential, including gene family, KEGG Ortholog, and metabolic pathway/module abundance.
Measured: Baseline, week 5, and week 10
Fecal calprotectin measured by ELISA
Fecal calprotectin concentration will be measured in stool samples using an ELISA assay. Results will be reported as fecal calprotectin concentration, with higher values indicating greater intestinal inflammation.
Measured: Baseline, weeks 5 and 10
Fecal Short Chain Fatty Acid measured by LC-MS/MS
Concentrations of fecal short-chain fatty acids, including acetate, propionate, butyrate, and branched-chain fatty acids, will be quantified using LC-MS/MS. Results will be reported as fecal SCFA concentrations.
Measured: Baseline, weeks 5 and 10
Secondary outcomes (4)
Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score
Neurogenic bowel dysfunction will be assessed using the Neurogenic Bowel Dysfunction Score. Total scores range from 0 to 47, with higher scores indicating more severe bowel dysfunction.
Measured: Baseline, weeks 5 and 10
Colonic transit measured by the Sitz marker test
Colonic transit will be assessed using the Sitz marker test. Participants will ingest a capsule containing radiopaque markers, and abdominal X-rays will be used to quantify the number and distribution of retained markers. Greater marker retention indicates slower colonic transit.
Measured: Baseline, week 10
Constipation severity measured by the Constipation Severity Instrument
Constipation severity will be assessed using the Constipation Severity Instrument (CSI), a 16-item questionnaire with total scores ranging from 0 to 73, where higher scores indicate greater constipation severity.
Measured: Baseline, weeks 5 and 10
Stool consistency measured by the Bristol Stool Form Scale
Stool consistency will be assessed using the Bristol Stool Form Scale, a 7-point scale ranging from Type 1, separate hard lumps, to Type 7, entirely liquid stool. Types 3-4 generally reflect more normal stool form.
Measured: Baseline, weeks 5 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Oct 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Li, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640152
- Sponsor's protocol ID
- 1519842
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results, including clinical, dietary, bowel function, metabolomic, and microbiome-derived datasets, will be shared within 12 months of primary publication or study completion, whichever occurs first. Processed clinical and omics datasets will be shared through the Open Data Commons for Spinal Cord Injury (ODC-SCI) and Vivli.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI
- ClinicalTrials.gov ID
- NCT07640152
- Acronym / sponsor ID
- 1519842
- Conditions
- Spinal Cord Injury
- Keywords
- gut microbiome, bowel dysfunction, fermented food
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 10 Jun 2026 (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 goal of this clinical trial is to learn whether consuming a high fermented food diet improves bowel function and gut health in adults with chronic spinal cord injury (SCI). The study will also evaluate the feasibility and tolerability of consuming fermented foods daily for 10 weeks. The main questions it aims to answer are:
- Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI?
- Does fermented food intake change gut microbiome composition, short-chain fatty acid production, and intestinal inflammation?
Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes.
Participants will:
- Consume study foods daily for 10 weeks
- Attend 2 in-person study visits
- Collect stool samples at home and ship them overnight to the research team using provided collection kits and prepaid shipping materials
- Complete bowel health questionnaires and dietary recalls
- Undergo Sitz marker testing with abdominal X-rays to assess colonic transit
- Participate in biweekly monitoring contacts throughout the study period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Food Arm | Experimental | Other: fermented foods, Device: Sitz Marker TestFermented food arm: participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance. A 3-week ramp-up (weeks 1-3) will increase intake from 2 to 6 servings/day, followed by a 7-week full-intake phase (weeks 4-10). To avoid single-food dominance and improve microbiome diversity, participants will be required to consume ≥3 categories/day (e.g., vegetables, dairy, soy, tea, brine) and rotate through all core fermented food categories and consume a variety of items across a 2-3-day period. This will ensure all core items are consumed throughout the week. Core food items will be delivered biweekly. |
| Control Diet Arm | Placebo comparator | Other: Control diet, Device: Sitz Marker TestParticipants randomized to the control arm will receive non-fermented versions of the base foods consumed by the fermented foods arm and will be instructed to avoid fermented foods during the trial. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 18-70 years
- At least 1 year post-onset of spinal cord injury, consistent with chronic spinal cord injury
- Traumatic spinal cord injury involving cervical or thoracic levels
- American Spinal Injury Association Impairment Scale classification A-D
- Medically stable, with no recent hospitalizations or acute illnesses
Key exclusion criteria (11 listed)
- Antibiotic use within the past 4 weeks
- Active gastrointestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal obstruction
- Current intake of probiotics or fermented foods exceeding 3 servings per day
- Pregnancy or breastfeeding
- Recent major bowel surgery within the past 12 weeks
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 |
|---|---|---|
| fermented foodsParticipants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance. | Other | Fermented Food Arm |
| Control dietParticipants randomized to the control arm will receive non-fermented versions of the base foods consumed by the fermented food arm and will be instructed to avoid fermented foods during the trial. | Other | Control Diet Arm |
| Sitz Marker TestColonic transit time will be assessed using the Sitz marker test, a standardized radiopaque marker method for evaluating bowel motility. Participants will swallow a capsule containing radiopaque markers, and abdominal X-rays will be obtained on day 5 to determine the number and distribution of retained markers throughout the colon. Greater marker retention indicates slower colonic transit, whereas fewer retained markers indicate faster transit and improved bowel motility. | Device | Control Diet Arm, Fermented Food Arm |
Primary outcome
Fecal microbiome composition assessed by shotgun metagenomic sequencing
Time frame: Baseline, weeks 5 and 10
Stool samples will be analyzed using shotgun metagenomic sequencing to characterize gut microbial taxonomic composition. Outcomes may include relative abundance of bacterial taxa and alpha/beta diversity metrics.
Gut microbiome functional potential measured by shotgun metagenomic sequencing
Time frame: Baseline, week 5, and week 10
Shotgun metagenomic sequencing data will be used to assess microbial functional potential, including gene family, KEGG Ortholog, and metabolic pathway/module abundance.
Fecal calprotectin measured by ELISA
Time frame: Baseline, weeks 5 and 10
Fecal calprotectin concentration will be measured in stool samples using an ELISA assay. Results will be reported as fecal calprotectin concentration, with higher values indicating greater intestinal inflammation.
Fecal Short Chain Fatty Acid measured by LC-MS/MS
Time frame: Baseline, weeks 5 and 10
Concentrations of fecal short-chain fatty acids, including acetate, propionate, butyrate, and branched-chain fatty acids, will be quantified using LC-MS/MS. Results will be reported as fecal SCFA concentrations.
4 secondary outcomes
Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score
Time frame: Baseline, weeks 5 and 10
Colonic transit measured by the Sitz marker test
Time frame: Baseline, week 10
Constipation severity measured by the Constipation Severity Instrument
Time frame: Baseline, weeks 5 and 10
Stool consistency measured by the Bristol Stool Form Scale
Time frame: Baseline, weeks 5 and 10
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 23 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results, including clinical, dietary, bowel function, metabolomic, and microbiome-derived datasets, will be shared within 12 months of primary publication or study completion, whichever occurs first. Processed clinical and omics datasets will be shared through the Open Data Commons for Spinal Cord Injury (ODC-SCI) and Vivli.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented foods and Sitz Marker Test in people with Spinal Cord Injury, run by Ohio 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 13 inclusion and 11 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 23 Oct 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?
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 Jia Li, PhD (6146889094, jia.li@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiome composition assessed by shotgun metagenomic sequencing (time frame: Baseline, weeks 5 and 10). The study lists 4 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 23 Oct 2026.