Gluten-free Diet in PSC and IBD

Launched by INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE · Aug 30, 2023

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ClinConnect Summary

This clinical trial is studying whether a gluten-free diet can help patients with Primary Sclerosing Cholangitis (PSC) and Ulcerative Colitis (UC). PSC is a serious liver disease that often leads to liver transplants, while UC is a type of inflammatory bowel disease that affects the colon. Researchers believe that avoiding gluten, a protein found in wheat and other grains, may reduce symptoms and inflammation for these patients.

To participate in the trial, you need to be between 18 and 65 years old and have a confirmed diagnosis of either PSC or UC. For PSC, your liver enzyme levels must be higher than normal, and for UC, you should have a certain extent of colon involvement. Participants will follow a gluten-free diet and will be monitored for changes in their condition. It’s important to know that this trial is not open to individuals who already have a gluten-free diet, have certain other health conditions, or are currently taking specific medications. If you're interested, make sure you discuss it with your healthcare provider to see if you qualify!

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Eligibility criteria

• 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