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

Status: Recruiting
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or ERCP)

• Age 18 - 65 years

• ALP 1,5x higher than ULN

• Signed informed consent

• Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings

• Extension of affected colon \> 15cm

• Mayo score 0-4

• Signed informed consent

Contact Information
Primary
Pavel Drastich, Assoc. prof., M.D., Ph.D.
padr@ikem.cz
+420603869913
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 60
Treatments
Experimental: Primary sclerosing cholangitis
Experimental: Ulcerative Colitis
Sponsors
Collaborators: Czech Academy of Sciences
Leads: Institute for Clinical and Experimental Medicine

This content was sourced from clinicaltrials.gov