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

Not Applicable

Completed

• Conditions: Reduction of Intestinal Inflammatory Activity

• Registration Number: NCT04006886
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Primary Completion: 2019-05-09
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Last Update Submitted: 2019-07-03
• Study First Posted: 2019-07-05
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction of intestinal inflammatory activity	2 months	Expression of pro-inflammatory cytokines in gut mucosa (Sigma)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany