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RECRUITING Not applicable ClinicalTrials.gov

Microencapsulated Sodium Propionate in IBD Microbiota Modulation

Sponsor: University of Padova • ClinicalTrials.gov ID: NCT07883044

Registry updated: 2026-10-20
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Description

The goal of this clinical trial is to evaluate whether microencapsulated sodium propionate can modulate the gut microbiota and improve inflammatory and immunological parameters in adult patients with inflammatory bowel disease (IBD) in remission or with mild disease activity. The study will also compare its effects with those of sodium butyrate. The main questions it aims to answer are: * Does sodium propionate modify gut microbiota composition and metabolic pathways in patients with IBD? * Does sodium propionate influence inflammatory markers, immune cell balance (Treg/Th17), and quality of life? Researchers will compare sodium propionate to sodium butyrate to determine whether propionate provides similar or additional benefits in microbiota modulation and inflammation control. Participants will: * Take either microencapsulated sodium propionate or sodium butyrate daily for 45 days, followed by a washout period and crossover to the alternate treatment * Provide stool samples for microbiota analysis and blood samples for inflammatory cytokine assessment at predefined time points * Complete quality-of-life questionnaires (IBDQ) during the study period

Interventions

  • Microencapsulated sodium propiolate (Dietary supplement)
    Sodium propionate is administered as a microencapsulated oral formulation designed to ensure targeted delivery to the colon. This delivery system aims to enhance local availability of the compound and optimize its interaction with the intestinal microbiota.
  • Microencapsulated sodium Butyrate (Dietary supplement)
    Sodium butyrate is administered as a microencapsulated oral formulation designed to allow targeted release in the colon. This delivery approach is intended to maximize its local effects on the intestinal microbiota and mucosal environment.

Eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of Crohn's disease based on clinical, endoscopic, and histopathological evidence (colonoscopy performed within 2 months prior to enrollment) * Disease in remission or with mild clinical activity (Mayo score 0-1), confirmed by clinical, endoscopic, or histopathological findings * Age between 18 and 75 years * Ability to fully participate in all aspects of the clinical study Exclusion Criteria: * Severe disease activity and ulcerative colites diagnosis * Positive stool test for Clostridioides difficile * Pregnancy

Conditions

Crohn Disease

Locations

  • Edoardo V. Savarino — Padova, Italy
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record