Gluten-free Diet in PSC and IBD

NCT ID: NCT06026449

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Primary Sclerosing Cholangitis; Ulcerative Colitis; Biliary Tract Diseases; Biliary Disease Tract; Intestinal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primary sclerosing cholangitis

Group Type: EXPERIMENTAL

Gluten-free diet

Intervention Type: DIETARY_SUPPLEMENT

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Ulcerative Colitis

Group Type: EXPERIMENTAL

Gluten-free diet

Intervention Type: DIETARY_SUPPLEMENT

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Interventions

Gluten-free diet

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Czech Academy of Sciences

OTHER

Sponsor Role: collaborator

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Březina

Senior consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of clinical and experimental medicine

Prague, Prague, Czechia

Countries

Czechia

Other Identifiers

NU22-06-00269

Identifier Type: -

Identifier Source: org_study_id