Fermented foods for bowel health in adults with spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will compare a high fermented food diet to a control diet over 10 weeks in adults with chronic spinal cord injury and neurogenic bowel dysfunction. Participants will consume study foods daily, attend two in-person visits, and collect stool samples at home for microbiome, short-chain fatty acids, and inflammation analyses. Outcomes include changes in bowel symptoms, colonic transit, and gut microbiome composition, aiming to determine feasibility and tolerability of daily fermented foods. The study also uses the Sitz Marker test to assess transit and tracks adherence through dietary questionnaires and home specimen shipping. Conducted at Ohio State University, the trial will provide data on diet-based strategies to improve bowel health in SCI.

Why it matters

Who can join: the full rules

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

Where it's running

• Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Jia Li, PhD
• Email: jia.li@osumc.edu
• Phone: 6146889094

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.