NCT06026449Completed
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 27 Mar 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 7 Jan 2026
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Diseases
- Ulcerative colitis
- NCT number
- NCT06026449
What you commit to
- Study type: Interventional
- Participants enrolled: 51
- From 1 Jan 2023 to the primary completion date, 7 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Liver transplant recipients
- Biologic therapy
Other illness
- Patients with coeliac disease or wheat allergy
- PSC/AIH overlap syndrome
- Other causes of liver disease
- History of malignancy
- Patients with coeliac disease or wheat allergy
Other
- Patients on gluten-free diet
- 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
- Pregnant women
- Not signed informed consent
- CMV, Clostridium difficile enterocolitis in past 3 months
- Use of antibiotics in past 3 months
- Patients on gluten-free diet
- Pregnant women
- Not signed informed consent
- Methotrexate
- Prednison \> 10 mg
- Not signed informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.