Status:
ACTIVE_NOT_RECRUITING
Gluten-free Diet in PSC and IBD
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Collaborating Sponsors:
Czech Academy of Sciences
Conditions:
Primary Sclerosing Cholangitis
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 countr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06026449
Start Date
January 1 2023
End Date
December 31 2026
Last Update
January 8 2026
Active Locations (1)
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1
Institute of clinical and experimental medicine
Prague, Prague, Czechia, 14021