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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2019-07-01

Brief Summary

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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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Detailed Description

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Conditions

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Reduction of Intestinal Inflammatory Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gluten-free diet

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No