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One bite of gluten: scientists track the immune alarm in celiac disease

NCT ID NCT05209568

Knowledge-focused Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers at Boston Children's Hospital are studying how the immune system reacts after a single oral dose of gluten powder. The study includes people with celiac disease and healthy controls, all of whom follow a gluten-free diet before the test. By measuring blood levels of interleukin-2 (IL-2) over four hours, the team aims to see whether this marker can reliably signal an immune response to gluten.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gluten powder
What this could lead to
If researchers map how IL-2 rises after gluten, this could help doctors test new celiac treatments faster and with fewer gut biopsies.
What could go wrong
This is a single-dose study, so it cannot show long-term effects or prove that IL-2 predicts every immune reaction. Some participants may have uncomfortable gluten symptoms.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 101 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. On a gluten-free diet for ≥ 4 weeks 2. Willing to consume gluten for research 3. For the celiac disease arm, diagnosis confirmed by serology and/or histology Exclusion Criteria: 1. Pregnancy 2. Wheat allergy 3. Type 1 diabetes 4. BMI z-score \< -2 5. History of more than minimal symptoms following gluten exposure on a gluten-free diet 6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

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Conditions

The condition(s) this trial relates to.

celiac disease Digestive System Diseases digestive system disorder intestinal disorder malabsorption syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease Celiac disease in children Digestive system disease Gastrointestinal diseases Gluten sensitivity Intestinal disease Malabsorption syndromes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

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Other studies related to the condition(s) this trial covers.