Gluten-free Diet in PSC and IBD

January 7, 2026 updated by: Jan Březina, Institute for Clinical and Experimental Medicine

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Prague
      • Prague, Prague, Czechia, 14021
        • Institute of clinical and experimental medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (for PSC group):

  • 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

Exclusion Criteria (for PSC group):

  • Patients on gluten-free diet
  • Patients with coeliac disease or wheat allergy
  • Liver transplant recipients
  • PSC/AIH overlap syndrome
  • Other causes of liver disease
  • Radiologic or clinical signs of decompensated liver cirrhosis
  • Advanced liver cirrhosis (MELD score ˃ 15)
  • Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months
  • Use of antibiotics in past 3 months
  • History of malignancy
  • Pregnant women
  • Not signed informed consent

Inclusion criteria (for UC group):

  • Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings
  • Extension of affected colon > 15cm
  • Mayo score 0-4
  • Signed informed consent

Exclusion criteria (for UC group):

  • CMV, Clostridium difficile enterocolitis in past 3 months
  • Use of antibiotics in past 3 months
  • Patients with coeliac disease or wheat allergy
  • Patients on gluten-free diet
  • Pregnant women
  • Not signed informed consent
  • Biologic therapy
  • Methotrexate
  • Prednison > 10 mg
  • Not signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulcerative Colitis
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
Experimental: Primary sclerosing cholangitis
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of intestinal microbiome composition.
Time Frame: 6-12 months
16S-rRNA sequencing
6-12 months
Decrease of laboratory markers of cholestasis
Time Frame: 6-12 months
Change of alkaline phosphatase > 25% or normalisation.
6-12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of morphological signs of intestinal inflammation
Time Frame: 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)
6-12 months
Improvement of quality of life and symptoms of ulcerative colitis.
Time Frame: 6-12 months
UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
6-12 months
Improvement of quality of life and symptoms of primary sclerosing cholangitis
Time Frame: 6-12 months
PSC quality of life questionnaire (PSC PRO)
6-12 months
Changes of histopathological signs of intestinal inflammation
Time Frame: 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)
6-12 months
Change from baseline of liver stiffness.
Time Frame: 6-12 months
Shear-wave elastography (F0-F4)
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Collaborators

Czech Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

January 7, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU22-06-00269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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