Clinical trial NCT06026449: Gluten-free Diet in PSC and IBD
Official title: Effect of Gluten-free Diet on Clinical Symptoms, Immune Response and Microbiome in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Sclerosing Cholangitis
Ulcerative Colitis
Biliary Tract Diseases
Biliary Disease Tract
Intestinal Disease
Keywords: Primary sclerosing cholangitis
Cholangitis
Gluten-free diet
Ulcerative Colitis
Microbiome
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Czech Academy of Sciences
First posted: 2023-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, self-controlled pilot clinical trial
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Decrease of laboratory markers of cholestasis
timeFrame: 6-12 months
measure: Changes of intestinal microbiome composition.
timeFrame: 6-12 months
Secondary outcomes:
measure: Changes of morphological signs of intestinal inflammation
timeFrame: 6-12 months
measure: Improvement of quality of life and symptoms of ulcerative colitis.
timeFrame: 6-12 months
measure: Improvement of quality of life and symptoms of primary sclerosing cholangitis
timeFrame: 6-12 months
measure: Changes of histopathological signs of intestinal inflammation
timeFrame: 6-12 months
measure: Change from baseline of liver stiffness.
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute of clinical and experimental medicine
Study officials:
References: