RecruitingNot Applicable

Immune Responses to Gluten

United States400 participantsStarted 2023-01-15

Plain-language summary

This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

Who can participate

Age range

2 Years – 101 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 4 hours

Trial details

NCT IDNCT05209568

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Jocelyn A Silvester, MD, PhD

617-355-8880 jocelyn.silvester@childrens.harvard.edu

View on ClinicalTrials.gov More Celiac Disease trials