NCT04006886

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Reduction of Intestinal Inflammatory Activity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten-free diet	After run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months.

Timeline

• Start date: 2017-07-11
• Primary completion: 2019-05-09
• Completion: 2019-07-01
• First posted: 2019-07-05
• Last updated: 2019-07-05

Locations

1 site across 1 country: Germany