RECRUITINGINTERVENTIONAL
Immune Responses to Gluten
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten
About This Trial
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Who May Be Eligible (Plain English)
Who May Qualify:
1. On a gluten-free diet for ≥ 4 weeks
2. Willing to consume gluten for research
3. For the celiac disease arm, diagnosis confirmed by serology and/or histology
Who Should NOT Join This Trial:
1. Pregnancy
2. Wheat allergy
3. Type 1 diabetes
4. BMI z-score \< -2
5. History of more than minimal symptoms following gluten exposure on a gluten-free diet
6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. On a gluten-free diet for ≥ 4 weeks
2. Willing to consume gluten for research
3. For the celiac disease arm, diagnosis confirmed by serology and/or histology
Exclusion Criteria:
1. Pregnancy
2. Wheat allergy
3. Type 1 diabetes
4. BMI z-score \< -2
5. History of more than minimal symptoms following gluten exposure on a gluten-free diet
6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results
Treatments Being Tested
DIETARY_SUPPLEMENT
Gluten Powder
Single oral dose of gluten powder
Locations (2)
Children's Hospital Colorado
Aurora, Colorado, United States
Boston Children's Hospital
Boston, Massachusetts, United States