Gluten-free Diet in PSC and IBD

Institute for Clinical and Experimental Medicine

Status: Enrolling

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

Treatments: Dietary Supplement: Gluten-free diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06026449

NU22-06-00269

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Primary sclerosing cholangitis

Experimental group

Treatment:

Dietary Supplement: Gluten-free diet

Ulcerative Colitis

Experimental group

Treatment:

Dietary Supplement: Gluten-free diet