Fermented Foods and Bowel Health in SCI
ConditionSpinal Cord Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOhio State University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
fermented foods
Other interventionParticipants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.
Control diet
Other interventionParticipants 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
DeviceColonic 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Fermented Food ArmExperimental treatment 2 interventions
Group B: Control Diet ArmPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, weeks 5 and 102
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.
Time frame
Baseline, week 5, and week 103
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.
Time frame
Baseline, weeks 5 and 104
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.
Time frame
Baseline, weeks 5 and 10Secondary outcomes
1
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.
Time frame
Baseline, weeks 5 and 102
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.
Time frame
Baseline, week 103
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.
Time frame
Baseline, weeks 5 and 104
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.
Time frame
Baseline, weeks 5 and 10Sponsors and contacts
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Source ClinicalTrials.gov
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