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

NCT04006886 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2019-07-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel

    collaborator UNKNOWN

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-11
Primary Completion
2019-05-09
Completion
2019-07-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04006886 on ClinicalTrials.gov