Fermented Foods and Bowel Health in SCI
Key facts
- Who runs it
- Ohio State University
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 44 people, planned
- Started
- 1 Oct 2026
- Expected to end
- 31 Jul 2029
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- fermented foods
- Control diet
- Sitz Marker Test
- Record updated
- 23 October 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
- 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 take part
- Recent major bowel surgery within the past 12 weeks
- 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
- Active gastrointestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, or gastrointestinal obstruction
- Antibiotic use within the past 4 weeks
- Current intake of probiotics or fermented foods exceeding 3 servings per day
- Pregnancy or breastfeeding
- Unresolved fecal impaction
- Unstable bowel regimen that could interfere with accurate motility assessment
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in United States
- Ohio State UniversityColumbus, United StatesContact: Jia Li Li, PhDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
1. Does a high fermented food diet improve neurogenic bowel dysfunction symptoms and colonic transit in adults with SCI? 2. 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
The 2 groups in the trial
- Fermented Food ArmTreatment being tested
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.
Treatment: fermented foods and Sitz Marker Test
- Control Diet ArmPlacebo, for comparison
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.
Treatment: Control diet and Sitz Marker Test
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI
- Fit questions
- Built from NCT07640152, who can take part
- Record updated
- 23 October 2026