Fermented Foods and Bowel Health in SCI

Conditions

• Spinal Cord Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• fermented foods — OTHER
  Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.
• Control diet — OTHER
  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 Test — DEVICE
  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 Details

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

Key Dates

Start date

Aug 1, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

44 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fermented Food Arm
  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.
• Placebo Comparator: Control Diet Arm
  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.

Primary Outcome Measure

Fecal microbiome composition assessed by shotgun metagenomic sequencing [ Time Frame: Baseline, weeks 5 and 10 ]

Central Contacts

• Jia Li, PhD
  6146889094
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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