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

July 3, 2019 updated by: Marcus Tetzlaff, Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22081
        • University Medical Center Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of intestinal inflammatory activity
Time Frame: 2 months
Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
2 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Johannes Gutenberg University Mainz
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2017

Primary Completion (Actual)

May 9, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSt-GFD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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