Status:
RECRUITING
Immune Responses to Gluten
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Children's Hospital Colorado
Celiac Disease Foundation
Conditions:
Celiac Disease
Malabsorption Syndromes
Eligibility:
All Genders
2-101 years
Phase:
NA
Brief Summary
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Detailed Description
This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.
Eligibility Criteria
Inclusion
- On a gluten-free diet for ≥ 4 weeks
- Willing to consume gluten for research
- For the celiac disease arm, diagnosis confirmed by serology and/or histology
Exclusion
- Pregnancy
- Wheat allergy
- Type 1 diabetes
- BMI z-score \< -2
- History of more than minimal symptoms following gluten exposure on a gluten-free diet
- Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05209568
Start Date
January 15 2023
End Date
September 30 2029
Last Update
April 23 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02115