Gluten Challenge in Celiac Disease

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo university hospital - Rikshospitalet

Oslo, 0372, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten Challenge

Dietary Supplement

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

Primary outcomes

Transcriptome of gluten-specific T cells

Time frame: Day 6

Transcriptional differences of glutenspecific vs. unspecific T cells

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

Helse Sor-Ost
Stiftelsen Helse og Rehabilitering

Registry information

Important dates

Study start: 2017
Primary completion: 2025
Study completion: 2025
First posted: Jun 8, 2015
Registry last updated: Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed