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Gluten-free Diet in PSC and IBD

Primary Purpose

Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
Institute for Clinical and Experimental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring Primary sclerosing cholangitis, Cholangitis, Gluten-free diet, Ulcerative Colitis, Microbiome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Institute of clinical and experimental medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Primary sclerosing cholangitis

Ulcerative Colitis

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Improvement of quality of life and symptoms of ulcerative colitis.
UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
Improvement of quality of life and symptoms of primary sclerosing cholangitis
PSC quality of life questionnaire (PSC PRO)
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)
Change from baseline of liver stiffness.
Shear-wave elastography (F0-F4)

Full Information

First Posted
March 27, 2023
Last Updated
September 6, 2023
Sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Czech Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT06026449
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Clinical and Experimental Medicine
Collaborators
Czech Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Sclerosing Cholangitis, Ulcerative Colitis, Biliary Tract Diseases, Biliary Disease Tract, Intestinal Disease
Keywords
Primary sclerosing cholangitis, Cholangitis, Gluten-free diet, Ulcerative Colitis, Microbiome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, self-controlled pilot clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary sclerosing cholangitis
Arm Type
Experimental
Arm Title
Ulcerative Colitis
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten-free diet
Intervention Description
After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months
Primary Outcome Measure Information:
Title
Decrease of laboratory markers of cholestasis
Description
Change of alkaline phosphatase > 25% or normalisation.
Time Frame
6-12 months
Title
Changes of intestinal microbiome composition.
Description
16S-rRNA sequencing
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Changes of morphological signs of intestinal inflammation
Description
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
Title
Improvement of quality of life and symptoms of ulcerative colitis.
Description
UC Quality of life questionnaire (The Short Inflammatory Bowel Disease) Questionnaire)
Time Frame
6-12 months
Title
Improvement of quality of life and symptoms of primary sclerosing cholangitis
Description
PSC quality of life questionnaire (PSC PRO)
Time Frame
6-12 months
Title
Changes of histopathological signs of intestinal inflammation
Description
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
Title
Change from baseline of liver stiffness.
Description
Shear-wave elastography (F0-F4)
Time Frame
6-12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Drastich, Assoc. prof., M.D., Ph.D.
Phone
+420603869913
Email
padr@ikem.cz
Facility Information:
Facility Name
Institute of clinical and experimental medicine
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Brezina, M.D.
Phone
00420739602520
Email
jan.brezina@ikem.cz

12. IPD Sharing Statement

Plan to Share IPD
No

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Gluten-free Diet in PSC and IBD

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