Ireland
--:--IST
Latest
Ireland Needs 46,000 More Digital Specialists by 2030, EGFSN Report Warns Project Management Failures: Lessons for Healthcare FDA Approves Lilly's Weekly Insulin Onswik to Rival Awiqli WeBuild Programme: 50+ Women-Led Ventures and How to Apply Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Ireland Needs 46,000 More Digital Specialists by 2030, EGFSN Report Warns Project Management Failures: Lessons for Healthcare FDA Approves Lilly's Weekly Insulin Onswik to Rival Awiqli WeBuild Programme: 50+ Women-Led Ventures and How to Apply Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing
Clinical Trials in Czechia / NCT06026449
Active, not recruiting Not applicable

Gluten-free Diet in PSC and IBD

NCT06026449 · tracked via the Priya Life Science Czechia tracker
Sponsor
Institute for Clinical and Experimental Medicine
Phase
Not applicable
Started
2023-01-01
Last updated
2026-01-08

Condition(s) studied

Primary Sclerosing CholangitisUlcerative ColitisBiliary Tract DiseasesBiliary Disease TractIntestinal Disease

Investigational drug(s) / intervention(s)

Gluten-free diet

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of clinical and experimental medicine Prague Prague

More Institute for Clinical and Experimental Medicine trials in Czechia

Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia Starting soon
Pericoronary Adipocyte Size Gradient Recruiting
Use of Wearables to Detect Infections in Kidney Transplant Recipients Starting soon
Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure Recruiting
Gastric Pathophysiology in Diabetes Recruiting

Other trials for the same condition

Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD Enrolling by invitation
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD) Recruiting
A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis Active, not recruiting
The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease Active, not recruiting
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06026449 on ClinicalTrials.gov ↗ ← All trials in Czechia