Immune Responses to Gluten in Celiac Disease Study

This study is looking at how your body's immune system reacts after eating gluten. Researchers will give you a single dose of Gluten Powder to see how it affects your immune response. You might be able to join if you are between 2 and 101 years old, have been on a gluten-free diet for at least 4 weeks, and are willing to eat gluten for the study. If you have celiac disease, your diagnosis needs to be confirmed by blood tests or tissue samples. The main goal is to measure changes in a specific immune marker called interleukin-2 (IL-2) in your blood, 4 hours after you eat the gluten powder. The current status of this study is unclear, and it plans to enroll 400 participants.

Study design
This is an open-label study, meaning both you and the study staff will know what intervention you are receiving. It involves a single dose of gluten and plans to include 400 participants.
What's involved
You will provide a blood sample before and 4 hours after eating gluten powder.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured at baseline and 4 hours after taking the gluten powder.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05209568

Immune Responses to Gluten

Enrolling by Invitation
NAAges 2+Interventional
Boston Children's Hospital
~400 participants
Updated 2026-09-11 on ClinicalTrials.gov
What's tested:Gluten Powder

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten
Measured over Baseline, 4 hours
Celiac Disease
Malabsorption Syndromes
Digestive System Disease
Intestinal Disease
Gastrointestinal Diseases
Gluten Sensitivity
Celiac Disease in Children

NCT05209568

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

  • Children's Hospital Colorado

    Aurora, Coloradono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jocelyn A Silvester, MD, PhD · PRINCIPAL_INVESTIGATOR · McMaster University

This trial hasn't published a contact. View it on ClinicalTrials.gov

  • Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of glutenBaseline, 4 hours

    To determine the change in serum IL-2 level from baseline after a single oral dose of gluten