Clinical Research Directory
Browse clinical research sites, groups, and studies.
Microencapsulated Sodium Propionate in IBD Microbiota Modulation
Sponsor: University of Padova
Summary
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
Official title: Microencapsulated Sodium Propionate: a Potential Ally in Microbiota Modulation for the Treatment of Chronic Inflammatory Bowel Diseases
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-10-01
Completion Date
2029-01-30
Last Updated
2026-10-20
Healthy Volunteers
No
Conditions
Interventions
Microencapsulated sodium propiolate
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
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.
Locations (1)
Edoardo V. Savarino
Padova, Italy