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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

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 3, 2019
Last Update Posted Date July 4, 2019
Actual Study Start Date  ICMJE July 11, 2017
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Reduction of intestinal inflammatory activity [ Time Frame: 2 months ]
Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
Reduction of intestinal inflammatory activity [ Time Frame: 2 months ]
Expression of pro-inflammatoy cytokines in gut mucosa (Sigma)
Change History Complete list of historical versions of study NCT04006886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Inflammatory activity of the liver [ Time Frame: 2 months ]
    alkaline phosphatase (AP)
  • Reduction of inflammatory cells/markers in the blood [ Time Frame: 2 months ]
    stored blood samples, Pax-Gene
  • Quality of life [ Time Frame: 2 months ]
    questionnaire
  • Change of symptoms with change of diet. [ Time Frame: 2 months ]
    questionnaire
  • Changes in patients microbiota [ Time Frame: 2 months (5 months with follow-up) ]
    stool samples
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • Inflammatory activity of the liver [ Time Frame: 2 months ]
    alkaline phosphatase (AP)
  • Reduction of inflammatory cells/markers in the blood [ Time Frame: 2 months ]
    stored blood samples, Pax-Gene
  • Qualty of life [ Time Frame: 2 months ]
    questionnaire
  • Change of symptoms with change of diet. [ Time Frame: 2 months ]
    questionnaire
  • Changes in patients microbiota [ Time Frame: 2 months (5 months with follow-up) ]
    stool samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)
Official Title  ICMJE Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Reduction of Intestinal Inflammatory Activity
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date May 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006886
Other Study ID Numbers  ICMJE PSt-GFD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marcus Tetzlaff, Universitätsklinikum Hamburg-Eppendorf
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE
  • Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel
  • Johannes Gutenberg University Mainz
Investigators  ICMJE Not Provided
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP