Spinal Cord Injury
Conditions
Keywords
gut microbiome, bowel dysfunction, fermented food
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: 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
Interventions
OTHERfermented foods
Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.
OTHERControl 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.
DEVICESitz 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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal microbiome composition assessed by shotgun metagenomic sequencing | Baseline, 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 sequencing | Baseline, 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 ELISA | Baseline, 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/MS | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score | Baseline, weeks 5 and 10 | 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. |
| Colonic transit measured by the Sitz marker test | Baseline, week 10 | 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. |
| Constipation severity measured by the Constipation Severity Instrument | Baseline, weeks 5 and 10 | 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. |
| Stool consistency measured by the Bristol Stool Form Scale | Baseline, weeks 5 and 10 | 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. |
Countries
United States
Contacts
CONTACTJia Li, PhD
Outcome results
None listed