MedTrace Logo

Gluten-free Diet in PSC and IBD

NCT06026449 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Czech Academy of Sciences

    collaborator OTHER

  • Institute for Clinical and Experimental Medicine

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-01-07
Completion
2026-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06026449 on ClinicalTrials.gov