Fermented Foods and Bowel Health in SCI

High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI

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

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Other: fermented foods; Device: Sitz Marker Test; Other: Control diet

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia Li, PhD; Phone Number: 6146889094; Email: jia.li@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University
      • Contact: Jia Li Li, PhD; Phone Number: 6146889094; Email: jia.li@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; 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.
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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score	Neurogenic bowel dysfunction will be assessed using the Neurogenic Bowel Dysfunction Score. Total scores range from 0 to 47, with higher scores indicating more severe bowel dysfunction.	Baseline, weeks 5 and 10
Colonic transit measured by the Sitz marker test	Colonic transit will be assessed using the Sitz marker test. Participants will ingest a capsule containing radiopaque markers, and abdominal X-rays will be used to quantify the number and distribution of retained markers. Greater marker retention indicates slower colonic transit.	Baseline, week 10
Constipation severity measured by the Constipation Severity Instrument	Constipation severity will be assessed using the Constipation Severity Instrument (CSI), a 16-item questionnaire with total scores ranging from 0 to 73, where higher scores indicate greater constipation severity.	Baseline, weeks 5 and 10
Stool consistency measured by the Bristol Stool Form Scale	Stool consistency will be assessed using the Bristol Stool Form Scale, a 7-point scale ranging from Type 1, separate hard lumps, to Type 7, entirely liquid stool. Types 3-4 generally reflect more normal stool form.	Baseline, weeks 5 and 10

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: gut microbiome; fermented food; bowel dysfunction
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Digestive System Diseases; Gastrointestinal Diseases; Trauma, Nervous System; Spinal Cord Diseases; Intestinal Diseases; Spinal Cord Injuries; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Fermented Foods
• Other Study ID Numbers: 1519842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying published results, including clinical, dietary, bowel function, metabolomic, and microbiome-derived datasets, will be shared within 12 months of primary publication or study completion, whichever occurs first. Processed clinical and omics datasets will be shared through the Open Data Commons for Spinal Cord Injury (ODC-SCI) and Vivli.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No