NCT07883044Recruiting
Microencapsulated Sodium Propionate in IBD Microbiota Modulation
Microencapsulated Sodium Propionate: a Potential Ally in Microbiota Modulation for the Treatment of Chronic Inflammatory Bowel Diseases
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- University of Padova
- Diseases
- Crohn's disease
- NCT number
- NCT07883044
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Oct 2026 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe disease activity and ulcerative colites diagnosis
Other
- Positive stool test for Clostridioides difficile
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edoardo V. Savarino Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.