Trials / Completed
CompletedNCT04054544
Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)
A Gluten Challenge Study to Characterize Peripheral Blood and Intestinal Gluten-specific CD4+ T Cell Subsets in Patients With Celiac Disease
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Gluten powder 4g | Gluten powder 4g oral BID |
Timeline
- Start date
- 2020-08-28
- Primary completion
- 2021-06-23
- Completion
- 2021-06-23
- First posted
- 2019-08-13
- Last updated
- 2023-03-06
- Results posted
- 2023-03-06
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04054544. Inclusion in this directory is not an endorsement.