Recruiting

High Fermented Foods

Sponsor:

Ohio State University

Code:

NCT07640152

Conditions

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

fermented foods

Control diet

Sitz Marker Test

Study Details

Brief 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

Spinal Cord Injury

Study ID

NCT07640152

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. Three or fewer bowel movements per week
2. More than 60 minutes required per bowel care routine
3. Symptoms of incomplete evacuation
4. Abdominal distension
5. 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

Exclusion Criteria:

  • 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
  • Unstable bowel regimen that could interfere with accurate motility assessment
  • Inability to safely undergo Sitz marker testing, including any of the following:

1. Inability to swallow the capsule
2. Pregnancy, due to radiation exposure
3. Contraindication to abdominal X-ray procedures

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Fecal microbiome composition assessed by shotgun metagenomic sequencing [ Time Frame: Baseline, weeks 5 and 10 ]
  • Gut microbiome functional potential measured by shotgun metagenomic sequencing [ Time Frame: Baseline, week 5, and week 10 ]
  • Fecal calprotectin measured by ELISA [ Time Frame: Baseline, weeks 5 and 10 ]
  • Fecal Short Chain Fatty Acid measured by LC-MS/MS [ Time Frame: Baseline, weeks 5 and 10 ]

Central Contacts and Locations

Central contacts

Jia Li, PhD

6146889094jia.li@osumc.edu

Locations

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Jia Li Li, PhD

6146889094jia.li@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • gut microbiome
  • bowel dysfunction
  • fermented food

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.