Gluten-free Diet in PSC and IBD

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026449
• Other study ID #: NU22-06-00269
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: September 2023
• Source: Institute for Clinical and Experimental Medicine
• Contact: Pavel Drastich, Assoc. prof., M.D., Ph.D.
• Phone: +420603869913
• Email: padr[@]ikem.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Disease Tract
• Biliary Tract Diseases
• Cholangitis
• Cholangitis, Sclerosing
• Colitis
• Colitis, Ulcerative
• Gallbladder Diseases
• Intestinal Disease
• Intestinal Diseases
• Primary Sclerosing Cholangitis
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Czechia	Institute of clinical and experimental medicine	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Czech Academy of Sciences

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of laboratory markers of cholestasis	Change of alkaline phosphatase > 25% or normalisation.	6-12 months
Primary	Changes of intestinal microbiome composition.	16S-rRNA sequencing	6-12 months
Secondary	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)	6-12 months
Secondary	Improvement of quality of life and symptoms of ulcerative colitis.	UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)	6-12 months
Secondary	Improvement of quality of life and symptoms of primary sclerosing cholangitis	PSC quality of life questionnaire (PSC PRO)	6-12 months
Secondary	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)	6-12 months
Secondary	Change from baseline of liver stiffness.	Shear-wave elastography (F0-F4)	6-12 months