Gluten Challenge in Celiac Disease

July 12, 2020 updated by: Knut E. A. Lundin, Oslo University Hospital

Up till 30 participants with celiac disease on a glutenfree diet are asked to consume gluten containing cookies or bread for 3 days.

Questionnaires and sampling of blood is done before, during and after.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Before and 6 days after start of gluten challenge, blood samples will be collected and analysed by using HLA-tetramers to identify and purify CD4+ gluten-specific T cells by flow cytometry. T cells will undergo transcriptome analysis to get an insight in signalling of antigen-specific cells. Other cell populations like CD8+ T cells and γδ T cells will also be analyzed by flow cytometry.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Celiac disease confirmed by biopsy
  • Age 18 - 80 years
  • Gluten free diet last 6 months
  • Subject has received information and signed the informed consent form

Exclusion Criteria:

  • Pregnant or breast feeding
  • Probability of participant becoming pregnant (f.ex. by not using adequate sexual prevention by woman in fertile age)
  • Drugs influencing immune system used last 3 months
  • Current infectious disease of moderate or high severity
  • Other chronic active intestinal disease
  • Serious reaction on small amounts of gluten ingested

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Participants
Participants are subjected to gluten intervention in an unblinded fashion.
Dietary supplement: Gluten challenge
Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptome of gluten-specific T cells
Time Frame: Day 6
Transcriptional differences of glutenspecific vs. unspecific T cells
Day 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Helse Sor-Ost
Stiftelsen Helse og Rehabilitering

Investigators

  • Principal Investigator: Knut EA Lundin, MD PhD, Oslo University Hospital and University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ANTICIPATED)

August 1, 2028

Study Completion (ANTICIPATED)

August 1, 2028

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (ESTIMATE)

June 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 12, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/1237

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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