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

Reduction of Intestinal Inflammatory Activity Clinical Trial

— PSt-GFD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04006886
• Other study ID #: PSt-GFD
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 1, 2019
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Reduction of Intestinal Inflammatory Activity

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of intestinal inflammatory activity	Expression of pro-inflammatory cytokines in gut mucosa (Sigma)	2 months
Secondary	Inflammatory activity of the liver	alkaline phosphatase (AP)	2 months
Secondary	Reduction of inflammatory cells/markers in the blood	stored blood samples, Pax-Gene	2 months
Secondary	Quality of life	questionnaire	2 months
Secondary	Change of symptoms with change of diet.	questionnaire	2 months
Secondary	Changes in patients microbiota	stool samples	2 months (5 months with follow-up)