Exploring the effects of a gluten-free diet on patients with primary sclerosing cholangitis and ulcerative colitis

Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease

This study is testing if a gluten-free diet can help people with primary sclerosing cholangitis and ulcerative colitis feel better and reduce their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Institute for Clinical and Experimental Medicine (other gov)
• Drugs / interventions: Methotrexate
• Locations: 1 site (Prague)
• Trial ID: NCT06026449 on ClinicalTrials.gov

What this trial studies

This study investigates the potential therapeutic effects of a gluten-free diet (GFD) on patients suffering from primary sclerosing cholangitis (PSC) and ulcerative colitis (UC). It aims to determine whether avoiding gluten can reduce disease progression, alleviate symptoms, and decrease intestinal inflammation in these patients. The study will be conducted as a prospective self-controlled mono-centric intervention, where participants will follow a GFD and be monitored for changes in their condition. The research is based on previous evidence suggesting that gluten may have pro-inflammatory effects in autoimmune diseases.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a confirmed diagnosis of primary sclerosing cholangitis or ulcerative colitis.

Not a fit: Patients with coeliac disease, wheat allergy, or those already on a gluten-free diet are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a dietary intervention that significantly improves the health and quality of life for patients with PSC and UC.

How similar studies have performed: While there is emerging evidence supporting dietary interventions in autoimmune diseases, this specific approach to PSC and UC is novel and has not been extensively tested.

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

Where this trial is running

Prague

• Institute of clinical and experimental medicine — Prague, Czechia (RECRUITING)

Study contacts

• Study coordinator: Pavel Drastich, Assoc. prof., M.D., Ph.D.

Conditions: Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease, Primary sclerosing cholangitis, Cholangitis, Gluten-free diet