Gluten-free Diet in Patients With Primary Sclerosing Chol... | NCT04006886

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

NCT04006886

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Jul 5, 2019Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Reduction of Intestinal Inflammatory Activity

Interventions

Gluten-free diet

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 11, 2017Actual

Primary Completion Date

May 9, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Jul 2, 2019

First Submission Date that Met QC Criteria

Jul 2, 2019

First Posted Date

Jul 5, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2019

Last Update Posted Date

Jul 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcus Tetzlaff, study coordinator, Universitätsklinikum Hamburg-EppendorfPrincipal Investigator

Lead Sponsor

Universitätsklinikum Hamburg-EppendorfOTHER

Collaborators

Name	Class
Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel	UNKNOWN
Johannes Gutenberg University Mainz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of intestinal inflammatory activity	Expression of pro-inflammatory cytokines in gut mucosa (Sigma)	2 months

Secondary Outcomes

Measure	Description	Time Frame
Inflammatory activity of the liver	alkaline phosphatase (AP)	2 months
Reduction of inflammatory cells/markers in the blood	stored blood samples, Pax-Gene

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Hamburg-Eppendorf		Hamburg		22081	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36266939	Derived	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.

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747