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

Primary Purpose

Reduction of Intestinal Inflammatory Activity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduction of Intestinal Inflammatory Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammatory activity of the liver
alkaline phosphatase (AP)
Reduction of inflammatory cells/markers in the blood
stored blood samples, Pax-Gene
Quality of life
questionnaire
Change of symptoms with change of diet.
questionnaire
Changes in patients microbiota
stool samples

Full Information

First Posted
July 2, 2019
Last Updated
July 3, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT04006886
Brief Title
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)
Acronym
PSt-GFD
Official Title
Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Johannes Gutenberg University Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction of Intestinal Inflammatory Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten-free diet
Intervention Description
After run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months.
Primary Outcome Measure Information:
Title
Reduction of intestinal inflammatory activity
Description
Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Inflammatory activity of the liver
Description
alkaline phosphatase (AP)
Time Frame
2 months
Title
Reduction of inflammatory cells/markers in the blood
Description
stored blood samples, Pax-Gene
Time Frame
2 months
Title
Quality of life
Description
questionnaire
Time Frame
2 months
Title
Change of symptoms with change of diet.
Description
questionnaire
Time Frame
2 months
Title
Changes in patients microbiota
Description
stool samples
Time Frame
2 months (5 months with follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
22081
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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