Summary
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Conditions
Celiac Disease, Malabsorption Syndromes, Digestive System Disease, Intestinal Disease, Gastrointestinal Diseases, Gluten Sensitivity, Celiac Disease in Children
Recruitment Status
Recruiting
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 Criteria:
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 Criteria:
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
Intervention
Intervention Type
Intervention Name
Dietary Supplement
Gluten Powder
Phase
Not Applicable
Gender
All
Min Age
2 Years
Max Age
101 Years
Download Date
January 16, 2024
Principal Investigator
Jocelyn A Silvester, MD, PhD
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
Marisa Stahl, MD, MSCS
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: