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OpenTrials
Completed

NCT Number: NCT04006886

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

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.

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Key information

Conditions

Reduction of Intestinal Inflammatory Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 22081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free diet

Dietary Supplement

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

Primary outcomes

  1. Reduction of intestinal inflammatory activity

    Time frame: 2 months

    Expression of pro-inflammatory cytokines in gut mucosa (Sigma)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PSt-GFD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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