Trials / Active Not Recruiting
Active Not RecruitingNCT06026449
Gluten-free Diet in PSC and IBD
Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Institute for Clinical and Experimental Medicine · Other Government
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Primary Sclerosing Cholangitis
- Ulcerative Colitis
- Biliary Tract Diseases
- Biliary Disease Tract
- Intestinal Disease
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2026-01-07
- Completion
- 2026-12-31
- First posted
- 2023-09-07
- Last updated
- 2026-01-08
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT06026449. Inclusion in this directory is not an endorsement.