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

Reduction of Intestinal Inflammatory Activity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Reduction of Intestinal Inflammatory Activity

• NCT number: NCT04006886
• Study type: Interventional
• Source: Universitätsklinikum Hamburg-Eppendorf
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Completion date: July 1, 2019