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Gluten Challenge in Celiac Disease

Gluten Challenge in Celiac Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02464150
Enrollment
99
Registered
2015-06-08
Start date
2017-04-01
Completion date
2025-05-13
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease

Keywords

gluten, antigen-specific T cells, transcriptome

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTGluten challenge

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

Sponsors

Stiftelsen Helse og Rehabilitering
CollaboratorOTHER
Helse Sor-Ost
CollaboratorOTHER_GOV
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Transcriptome of gluten-specific T cellsDay 6Transcriptional differences of glutenspecific vs. unspecific T cells

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026