NCT02464150

Gluten Challenge in Celiac Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten challenge	Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.

Timeline

• Start date: 2017-04-01
• Primary completion: 2025-05-13
• Completion: 2025-05-13
• First posted: 2015-06-08
• Last updated: 2025-06-22

Locations

1 site across 1 country: Norway