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

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ClinicalTrials.gov Identifier: NCT04006886
Recruitment Status : Completed
First Posted : July 3, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborators:
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Marcus Tetzlaff, Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Condition or disease Intervention/treatment Phase
Reduction of Intestinal Inflammatory Activity Dietary Supplement: Gluten-free diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : May 9, 2019
Actual Study Completion Date : July 1, 2019



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Reduction of intestinal inflammatory activity [ Time Frame: 2 months ]
    Expression of pro-inflammatory cytokines in gut mucosa (Sigma)


Secondary Outcome Measures :
  1. Inflammatory activity of the liver [ Time Frame: 2 months ]
    alkaline phosphatase (AP)

  2. Reduction of inflammatory cells/markers in the blood [ Time Frame: 2 months ]
    stored blood samples, Pax-Gene

  3. Quality of life [ Time Frame: 2 months ]
    questionnaire

  4. Change of symptoms with change of diet. [ Time Frame: 2 months ]
    questionnaire

  5. Changes in patients microbiota [ Time Frame: 2 months (5 months with follow-up) ]
    stool samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006886


Locations
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Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 22081
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel
Johannes Gutenberg University Mainz

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Responsible Party: Marcus Tetzlaff, study coordinator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04006886     History of Changes
Other Study ID Numbers: PSt-GFD
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases