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Fermented Foods and Bowel Health in SCI

5 juin 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

44

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Ohio
      • Columbus, Ohio, États-Unis, 43210
        • Ohio State University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: 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.
Dispositif: 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.
Comparateur placebo: 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.
Dispositif: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fecal microbiome composition assessed by shotgun metagenomic sequencing
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Neurogenic bowel dysfunction measured by the Neurogenic Bowel Dysfunction Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ohio State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 juillet 2029

Achèvement de l'étude (Estimé)

31 juillet 2029

Dates d'inscription aux études

Première soumission

27 mai 2026

Première soumission répondant aux critères de contrôle qualité

5 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1519842

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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