NCT05209568 · Boston Children's Hospital
Immune Responses to Gluten
What this study is about
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
View original scientific description
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.
Interventions
DIETARY_SUPPLEMENT
Gluten Powder
Single oral dose of gluten powder
Primary outcome measures
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
Time frame: Baseline, 4 hours
To determine the change in serum IL-2 level from baseline after a single oral dose of gluten
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Aurora, Colorado
- Boston, Massachusetts
Collaborators
Children's Hospital Colorado, Celiac Disease Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2025 · Source of record for eligibility and locations