Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)

Status Completed

Clinical Trial Summary

This is a gluten challenge study to characterize peripheral blood and intestinal gluten specific cluster of differentiation 4 glycoprotein (CD4+) thymus lymphocyte (T cell) subsets in participants with Celiac Disease

Clinical Trial Description

This is a multi-site, open-label gluten challenge study to characterize peripheral blood and intestinal gluten specific CD4+ T cell subsets in participants with celiac disease (CeD). Participants will receive 8 grams (g) of gluten daily for 13 consecutive days. Blood samples will be taken at pre-dose, Day 6, and Day 14. Duodenal biopsy samples will also be collected on Day 14. Participants will also complete a symptom diary. ;

Study Design

Related Conditions & MeSH terms

Celiac Disease

Clinical Trial Details

NCT number	NCT04054544
Study type	Interventional
Source	Merck Sharp & Dohme LLC
Contact
Status	Completed
Phase	Early Phase 1
Start date	August 28, 2020
Completion date	June 23, 2021

View Details

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