An interventional study of Gluten Powder in Celiac Disease, Malabsorption Syndromes and Digestive System Disease, sponsored by Boston Children's Hospital. Enrolling by invitation at 2 sites in United States. Open to participants aged 2 Years to 101 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Other
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
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.
352 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's planned enrollment of 400 is above the median of 50 across 214 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology
Dietary Supplement: Gluten Powder
Individuals without a diagnosis of celiac disease
Dietary Supplement: Gluten Powder
Single oral dose of gluten powder
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
To determine the change in serum IL-2 level from baseline after a single oral dose of gluten
Time frame: Baseline, 4 hours
Plan to share: Yes — Individual participant demographic and cytokine data collected during the trial, after deidentification.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Researchers who provide a methodologically sound proposal
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Glutens