NCT04614571

T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge

TCR Sequencing and Transcriptional Profiling in Celiac Disease Patients Undergoing Gluten Challenge

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are: * Characterize the T cell receptor (TCR) repertoire in duodenal biopsy samples of participants pre- and post-challenge. * Compare for each patient the TCR repertoire of duodenal biopsy samples with the peripheral blood TCR repertoire of each study participant * Characterize the transcriptome of duodenal biopsy samples and blood from study participants pre- and post-challenge The secondary objectives are: * Ex vivo identification and validation of DQ-restricted gliadin specific TCRs. * Characterize the gluten-challenge induced changes in small intestine histology using standard for Celiac Disease (CeD) histological assessments

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten Powder	Administered orally daily for 14 days

Timeline

• Start date: 2020-11-02
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2020-11-04
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States