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NCT07640152

Fermented Foods and Bowel Health in SCI

Not Yet Recruiting
NAAges 18–70InterventionalTreatment
Ohio State University
~44 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:fermented foodsControl dietSitz Marker Test

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fecal microbiome composition assessed by shotgun metagenomic sequencing
Measured over Baseline, weeks 5 and 10
+3 more outcomes measured

Conditions

Spinal Cord Injury

Explore related trials

Neurogenic bladder dysfunctionSpinal Cord Injury

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Jia Li, PhD
[email protected]
6146889094
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Eligibility criteria

Inclusion

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:
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

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:

What this trial measures

  • Fecal microbiome composition assessed by shotgun metagenomic sequencingBaseline, weeks 5 and 10

    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.

  • Gut microbiome functional potential measured by shotgun metagenomic sequencingBaseline, week 5, and week 10

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

  • Fecal calprotectin measured by ELISABaseline, weeks 5 and 10

    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.

  • Fecal Short Chain Fatty Acid measured by LC-MS/MSBaseline, weeks 5 and 10

    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.