Gluten-free Diet in PSC and IBD

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 51 participants (planned 60)
    • Study completion date changed from estimate of Dec 31, 2026 to Jul 31, 2026
    • Eligibility criteria expanded, about 30 words
    • Site details revised
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jan 1, 2026 to Jan 7, 2026
    • Study completion date: Aug 30, 2026 to Dec 31, 2026
    • Site details revised
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Eligibility criteria revisedv2
  5. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study. Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.
Trial Details
NCT Number NCT06026449
Lead Sponsor Institute for Clinical and Experimental Medicine
Collaborators: Czech Academy of Sciences
Conditions
(from sponsor)		 Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease
Related terms Biliary Tract Diseases, Cholangitis, Cholangitis, Sclerosing, Colitis, Ulcerative, Intestinal Diseases
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov