Fermented Foods and Bowel Health in SCI

NCT07640152 | Not Yet Recruiting DMC

• 1 other identifier: 1519842
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

gut microbiome; bowel dysfunction; fermented food

Outcome Measures

Primary Outcomes (4)

• Fecal microbiome composition assessed by shotgun metagenomic sequencing

  Stool samples will be analyzed using shotgun metagenomic sequencing to characterize gut microbial taxonomic composition. Outcomes may include relative abundance of bacterial taxa and alpha/beta diversity metrics.

  Baseline, weeks 5 and 10

• Gut microbiome functional potential measured by shotgun metagenomic sequencing

  Shotgun metagenomic sequencing data will be used to assess microbial functional potential, including gene family, KEGG Ortholog, and metabolic pathway/module abundance.

  Baseline, week 5, and week 10

• Fecal calprotectin measured by ELISA

  Fecal calprotectin concentration will be measured in stool samples using an ELISA assay. Results will be reported as fecal calprotectin concentration, with higher values indicating greater intestinal inflammation.

  Baseline, weeks 5 and 10

• Fecal Short Chain Fatty Acid measured by LC-MS/MS

  Concentrations of fecal short-chain fatty acids, including acetate, propionate, butyrate, and branched-chain fatty acids, will be quantified using LC-MS/MS. Results will be reported as fecal SCFA concentrations.

  Baseline, weeks 5 and 10

Secondary Outcomes (4)

• Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score

  Baseline, weeks 5 and 10

• Colonic transit measured by the Sitz marker test

  Baseline, week 10

• Constipation severity measured by the Constipation Severity Instrument

  Baseline, weeks 5 and 10

• Stool consistency measured by the Bristol Stool Form Scale

  Baseline, weeks 5 and 10

Study Arms (2)

Fermented Food Arm

EXPERIMENTAL

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.

Other: fermented foods; Device: Sitz Marker Test

Control Diet Arm

PLACEBO COMPARATOR

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.

Other: Control diet; Device: Sitz Marker Test

Interventions

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.

Control Diet Arm

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.

Fermented Food Arm

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.

Control Diet Arm; Fermented Food Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Inability to swallow the capsule
• Pregnancy, due to radiation exposure
• Contraindication to abdominal X-ray procedures

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Intestinal Diseases

Interventions

Fermented Foods

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Jia Li, PhD

CONTACT

6146889094; jia.li@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 12 months after publication of the primary study results or 12 months after study completion, whichever occurs first, and will remain available indefinitely.
• Access Criteria: De-identified data will be available to qualified investigators for scientifically sound research purposes. Requests will be reviewed by the study investigators and/or repository governance committees. Data will be provided under applicable data use agreements and in accordance with institutional and federal human subjects protections.

Locations

US (1)