Gluten Challenge in Celiac Disease

Oslo University Hospital99 enrolled

Overview

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.

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

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Celiac Disease

Interventions

Gluten challengeDIETARY_SUPPLEMENT

Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Oslo university hospital - Rikshospitalet

Oslo, Norway

Outcomes

Primary Outcomes

Transcriptome of gluten-specific T cells

Transcriptional differences of glutenspecific vs. unspecific T cells

Time frame: Day 6

Data from ClinicalTrials.gov

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