Gluten-free Diet in PSC and IBD

Not Applicable

Recruiting

• Conditions: Biliary Tract Diseases; Biliary Disease Tract; Primary Sclerosing Cholangitis; Ulcerative Colitis; Intestinal Disease
• Interventions: Dietary Supplement: Gluten-free diet

• Registration Number: NCT06026449
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-09-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2026-01-01
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary sclerosing cholangitis	Gluten-free diet	-
Ulcerative Colitis	Gluten-free diet	-

Primary Outcome Measures

Name	Time	Method
Decrease of laboratory markers of cholestasis	6-12 months	Change of alkaline phosphatase \> 25% or normalisation.
Changes of intestinal microbiome composition.	6-12 months	16S-rRNA sequencing

Secondary Outcome Measures

Name	Time	Method
Changes of morphological signs of intestinal inflammation	6-12 months	Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)
Improvement of quality of life and symptoms of ulcerative colitis.	6-12 months	UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
Improvement of quality of life and symptoms of primary sclerosing cholangitis	6-12 months	PSC quality of life questionnaire (PSC PRO)
Changes of histopathological signs of intestinal inflammation	6-12 months	Nancy histological index (Grade 0 - no histological significant disease; Grade 1 - chronic inflammatory infiltrate with no acute inflammatory infiltrate; Grade 2 - Mildly active disease, Grade 3 - Moderately active disease; Grade 4 - Severly active disease)
Change from baseline of liver stiffness.	6-12 months	Shear-wave elastography (F0-F4)

Trial Locations

Locations (1)

Institute of clinical and experimental medicine; 🇨🇿 Prague, Czechia