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

NCT04006886 | Completed

• 1 other identifier: PSt-GFD
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Reduction of Intestinal Inflammatory Activity

Outcome Measures

Primary Outcomes (1)

• Reduction of intestinal inflammatory activity

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

  2 months

Secondary Outcomes (5)

• Inflammatory activity of the liver

  2 months

• Reduction of inflammatory cells/markers in the blood

  2 months

• Quality of life

  2 months

• Change of symptoms with change of diet.

  2 months

• Changes in patients microbiota

  2 months (5 months with follow-up)

Interventions

Gluten-free diet DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel: collaborator
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 22081, Germany

Location

Related Publications (1)

• Liwinski T, Hubener S, Henze L, Hubener P, Heinemann M, Tetzlaff M, Hiller MI, Jagemann B, Surabattula R, Leeming D, Karsdal M, Monguzzi E, Schachschal G, Rosch T, Bang C, Franke A, Lohse AW, Schuppan D, Schramm C. A prospective pilot study of a gluten-free diet for primary sclerosing cholangitis and associated colitis. Aliment Pharmacol Ther. 2023 Jan;57(2):224-236. doi: 10.1111/apt.17256. Epub 2022 Oct 20.

  PMID: 36266939 DERIVED

MeSH Terms

Interventions

Diet, Gluten-Free

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study coordinator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: July 11, 2017
• Primary Completion: May 9, 2019
• Study Completion: July 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DE (1)