Gluten Challenge in Celiac Disease

  • STATUS
    Recruiting
  • End date
    Aug 24, 2028
  • participants needed
    10
  • sponsor
    Oslo University Hospital
Updated on 24 February 2022
gluten

Summary

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.

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 T cells will also be analyzed by flow cytometry.

Details
Condition Celiac Disease
Treatment Gluten challenge
Clinical Study IdentifierNCT02464150
SponsorOslo University Hospital
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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