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ACTIVE NOT RECRUITING
NCT06026449
NA

Gluten-free Diet in PSC and IBD

Sponsor: Institute for Clinical and Experimental Medicine

View on ClinicalTrials.gov

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.

Official title: Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-01-01

Completion Date

2026-12-31

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Gluten-free diet

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Locations (1)

Institute of clinical and experimental medicine

Prague, Prague, Czechia