Gluten Challenge in Celiac Disease

University of Oslo (UIO)

Status: Completed

Conditions: Celiac Disease

Treatments: Dietary Supplement: Gluten challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT02464150

2013/1237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

Participants

Experimental group

Description:

Participants are subjected to gluten intervention in an unblinded fashion.

Treatment:

Dietary Supplement: Gluten challenge