RecruitingNot ApplicableNCT05209568
Immune Responses to Gluten
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
Sponsor
Boston Children's Hospital
Enrollment
400 participants
Start Date
Jan 15, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Eligibility
Min Age: 2 YearsMax Age: 101 Years
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
DIETARY_SUPPLEMENTGluten Powder
Single oral dose of gluten powder
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05209568
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