Gluten-free Diet in PSC and IBD

Sponsor

Institute for Clinical and Experimental Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT06026449

Collaborator

Czech Academy of Sciences (Other)

Enrollment

Location

Arms

43.9

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Sclerosing Cholangitis Ulcerative Colitis Biliary Tract Diseases Biliary Disease Tract Intestinal Disease	Dietary Supplement: Gluten-free diet	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, self-controlled pilot clinical trialProspective, self-controlled pilot clinical trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Aug 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Primary sclerosing cholangitis	Dietary Supplement: Gluten-free diet After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months
Experimental: Ulcerative Colitis	Dietary Supplement: Gluten-free diet After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Arm

Intervention/Treatment

Experimental: Primary sclerosing cholangitis

Dietary Supplement: Gluten-free diet

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Experimental: Ulcerative Colitis

Dietary Supplement: Gluten-free diet

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Outcome Measures

Primary Outcome Measures

Decrease of laboratory markers of cholestasis [6-12 months]
Change of alkaline phosphatase > 25% or normalisation.
Changes of intestinal microbiome composition. [6-12 months]
16S-rRNA sequencing

Secondary Outcome Measures

Changes of morphological signs of intestinal inflammation [6-12 months]
Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)
Improvement of quality of life and symptoms of ulcerative colitis. [6-12 months]
UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
Improvement of quality of life and symptoms of primary sclerosing cholangitis [6-12 months]
PSC quality of life questionnaire (PSC PRO)
Changes of histopathological signs of intestinal inflammation [6-12 months]
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)
Change from baseline of liver stiffness. [6-12 months]
Shear-wave elastography (F0-F4)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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