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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:
Researchers will compare a high fermented food diet to a control diet to evaluate effects on bowel health and gut microbiome outcomes.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fermented Food Arm | Experimental | 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. |
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| Control Diet Arm | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fermented foods | Other | Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance. |
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| 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 |
| 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 |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Li, PhD | Contact | 6146889094 | jia.li@osumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University | Columbus | Ohio | 43210 | United States |
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.
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.
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.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000074421 | Fermented Foods |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Control diet | Other | 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. |
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| Sitz Marker Test | Device | 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. |
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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 |
| D014947 | Wounds and Injuries |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |