Gluten-free Diet in PSC and IBD

N/AActive Not RecruitingNCT06026449

Institute for Clinical and Experimental Medicine60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Sclerosing Cholangitis Ulcerative Colitis Biliary Tract Diseases Biliary Disease Tract

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Decrease of laboratory markers of cholestasis

Change of alkaline phosphatase \> 25% or normalisation.

Time frame: 6-12 months

Changes of intestinal microbiome composition.

16S-rRNA sequencing

Time frame: 6-12 months

Secondary Outcomes

Changes of morphological signs of intestinal inflammation

Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)

Time frame: 6-12 months

Improvement of quality of life and symptoms of ulcerative colitis.

UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)

Time frame: 6-12 months

Improvement of quality of life and symptoms of primary sclerosing cholangitis

PSC quality of life questionnaire (PSC PRO)

Time frame: 6-12 months

Changes of histopathological signs of intestinal inflammation

Nancy histological index (Grade 0 - no histological significant disease; Grade 1 - chronic inflammatory infiltrate with no acute inflammatory infiltrate; Grade 2 - Mildly active disease, Grade 3 - Moderately active disease; Grade 4 - Severly active disease)

Time frame: 6-12 months

Change from baseline of liver stiffness.

Shear-wave elastography (F0-F4)

Time frame: 6-12 months

Gluten-free Diet in PSC and IBD

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes