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Microencapsulated Sodium Propionate in IBD Microbiota Modulation

RecruitingNAAges 18 Years - 75 YearsAllUniversity of Padova
NCT07883044 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Microencapsulated sodium propiolate
  • Microencapsulated sodium Butyrate
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Where

1 site
Edoardo V. Savarino
Padova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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