Clinical Trial

Gluten-free Diet in PSC and IBD

Active, Not Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-30; most recent amendment 2026-01-07.
Status change: Recruiting → Active, Not Recruiting 2026-01-07
Trial Details
NCT Number NCT06026449
Lead Sponsor Institute for Clinical and Experimental Medicine
Collaborators: Czech Academy of Sciences
Conditions Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease
Enrollment 60 participants
Start Date 2023-01-01
Primary Completion 2026-01-07 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-08