NCT03409796

Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to characterize changes in gluten-specific T cells and pathology in the small intestine with specific focus on biomarkers likely to change with therapeutic celiac disease (CeD) treatment.

Detailed description

Gluten challenge studies are used to test the effectiveness of therapies designed to prevent immune response to gluten in participants with CeD. The study will enroll approximately 20 participants. Participants will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the two treatment groups: * Group A: Gluten 3 gm * Group B: Gluten 10 gm All participants will be asked to take an oral dose of gluten at the same time on Days 1 to 14 throughout the study. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 10 weeks. Participants will visit to the clinic on Day -45 and will be contacted for follow-up assessment on Days 15 to 42.

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten	Gluten powder.

Timeline

• Start date: 2018-04-24
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2018-01-24
• Last updated: 2022-05-24
• Results posted: 2020-08-18

Locations

2 sites across 1 country: United States