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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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.
- Reduction of intestinal inflammatory activity [ Time Frame: 2 months ]Expression of pro-inflammatory cytokines in gut mucosa (Sigma)
- 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
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
|University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 22081|