Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) (PSt-GFD)

Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study

Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.

Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).

Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.

Proof of hypothesis:

• Pilot study with n=20 patients with PSC
• Explorative, open-label, mono-centric study
• Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

Study Overview

• Status: Completed
• Conditions: Reduction of Intestinal Inflammatory Activity
• Intervention / Treatment: Dietary supplement: Gluten-free diet

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22081
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

Exclusion Criteria:

• patients with coeliac disease or wheat allergy
• patients with active colitis
• patients already on gluten-free diet
• liver transplanted patients
• patients also diagnosed with autoimmune hepatites (PSC-AIH overlap)
• coloscopy within 2 months before study
• Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study
• antibiotics within 3 month before study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of intestinal inflammatory activity	Expression of pro-inflammatory cytokines in gut mucosa (Sigma)	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory activity of the liver	alkaline phosphatase (AP)	2 months
Reduction of inflammatory cells/markers in the blood	stored blood samples, Pax-Gene	2 months
Quality of life	questionnaire	2 months
Change of symptoms with change of diet.	questionnaire	2 months
Changes in patients microbiota	stool samples	2 months (5 months with follow-up)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Johannes Gutenberg University Mainz; Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): May 9, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis; Cholangitis, Sclerosing
• Other Study ID Numbers: PSt-GFD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No