NCT05209568NARecruitingAccepts Healthy Volunteers
Immune Responses to Gluten
Boston Children's Hospital
Start Date
1/15/2023
Completion Date
9/30/2029
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
Age Range: 2 years to 101 years
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
Interventions
DIETARY_SUPPLEMENT
Gluten Powder
Conditions
Celiac DiseaseMalabsorption SyndromesDigestive System DiseaseIntestinal DiseaseGastrointestinal DiseasesGluten SensitivityCeliac Disease in Children
Locations
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States