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

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Conditions

Reduction of Intestinal Inflammatory Activity

Treatments

Dietary Supplement: Gluten-free diet

Study type

Interventional

Funder types

Other

Identifiers

NCT04006886

PSt-GFD

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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