Overview
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
Description
This randomized, double-blind, crossover pilot clinical trial is designed to investigate the effects of microencapsulated sodium propionate on gut microbiota modulation in patients with inflammatory bowel disease (IBD), and to compare these effects with those of sodium butyrate.
Short-chain fatty acids (SCFAs), including butyrate and propionate, are key metabolites produced by intestinal microbiota through the fermentation of dietary fibers. While butyrate has been widely studied and applied in clinical settings, propionate remains less explored despite evidence suggesting its role in regulating intestinal motility, immune responses, and metabolic pathways. The development of a microencapsulated formulation of sodium propionate enables targeted delivery to the colon, potentially enhancing its therapeutic efficacy.
The study will enroll adult patients with Crohn's disease in remission or with mild disease activity. Participants will be randomly assigned to receive either microencapsulated sodium butyrate or sodium propionate for a defined treatment period, followed by a washout phase and subsequent crossover to the alternate treatment. This design allows each participant to serve as their own control, improving the ability to detect treatment-related differences.
The primary focus of the study is to characterize changes in gut microbiota composition and function using advanced shotgun metagenomic sequencing, with particular attention to microbial diversity and metabolic pathways. In parallel, the study will explore the immunomodulatory effects of propionate by assessing inflammatory cytokines and pathways associated with immune regulation.
Additionally, the study will examine the broader clinical impact of treatment through patient-reported outcomes related to quality of life. By integrating microbiological, immunological, and clinical data, this study aims to clarify the therapeutic potential of propionate and expand current knowledge on SCFA-based interventions in IBD management.
Eligibility
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
