Fermented Foods for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
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:
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
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 who have had a spinal cord injury (neck or upper back) for at least one year, are medically stable, and have ongoing bowel problems like infrequent movements, long routines, incomplete evacuation, or bloating. Participants must be able to safely eat fermented foods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Ramp-up Treatment
Participants gradually increase fermented food intake from 2 to 6 servings/day over 3 weeks
Full-intake Treatment
Participants consume ≥6 servings/day of fermented foods, rotating through categories to ensure diversity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fermented Foods
Trial Overview
The study compares a high fermented food diet to a regular control diet over 10 weeks in people with chronic spinal cord injury. It looks at whether eating more fermented foods improves bowel function and gut health using stool samples and X-rays.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
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