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Fermented Foods and Bowel Health in SCI

NCT07640152 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-06-10

No results posted yet for this study

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. 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

Conditions

Interventions

OTHER

fermented foods

Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.

OTHER

Control diet

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.

DEVICE

Sitz Marker Test

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.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640152 on ClinicalTrials.gov