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Fermented Foods and Bowel Health in SCI

5. juni 2026 opdateret af: Jia Li, Ohio State University

High Fermented Food Intake to Improve Gut Microbiome and Bowel Dysfunction in Individuals With SCI

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

44

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fermented Food Arm
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.
Andet: fermented foods
Participants randomized to the fermented foods arm will consume ≥6 servings/day of fermented foods after a graded ramp-up to minimize intolerance.
Enhed: Sitz 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.
Placebo komparator: Control Diet Arm
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.
Enhed: Sitz 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.
Andet: Control 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fecal microbiome composition assessed by shotgun metagenomic sequencing
Tidsramme: 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.
Baseline, weeks 5 and 10
Gut microbiome functional potential measured by shotgun metagenomic sequencing
Tidsramme: 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.
Baseline, week 5, and week 10
Fecal calprotectin measured by ELISA
Tidsramme: 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.
Baseline, weeks 5 and 10
Fecal Short Chain Fatty Acid measured by LC-MS/MS
Tidsramme: 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.
Baseline, weeks 5 and 10

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score
Tidsramme: 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.
Baseline, weeks 5 and 10
Colonic transit measured by the Sitz marker test
Tidsramme: 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.
Baseline, week 10
Constipation severity measured by the Constipation Severity Instrument
Tidsramme: 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.
Baseline, weeks 5 and 10
Stool consistency measured by the Bristol Stool Form Scale
Tidsramme: 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.
Baseline, weeks 5 and 10

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ohio State University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

31. juli 2029

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1519842

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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