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Tiny gluten doses spark immune changes in kids with celiac disease

NCT ID NCT07362654

Knowledge-focused Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how the immune system of children with celiac disease responds to tiny, controlled amounts of gluten. About 51 kids on a strict gluten-free diet will get either a placebo, a small dose (50 mg), or a larger dose (5 g) of gluten daily for three days. Researchers will analyze blood, stool, and urine samples to see if even tiny gluten exposures cause measurable immune changes, which could lead to better tests and care for celiac disease.

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 51 people

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

Started

Jul 2025

Expected to finish

Nov 2026

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

8 to 14 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age 8 to 14 years at study entry. * Diagnosis of celiac disease according to ESPGHAN 2020 criteria. * At least 18 months on a strict gluten-free diet (GFD). * Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion. * Asymptomatic from a gastrointestinal perspective in the preceding weeks. * Ability to swallow the gluten/placebo preparation. * Written informed consent from parents/legal guardians and assent from the child. Exclusion Criteria: * Obesity defined as BMI ≥ 95th percentile according to WHO criteria. * Diagnosed inflammatory bowel disease or diabetes mellitus. * Acute infectious illness at the time of inclusion. * Chronic hepatic, pulmonary, renal, or rheumatologic disease. * History of severe acute reactions to accidental gluten ingestion. * Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months. * Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.

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Conditions

The condition(s) this trial relates to.

autoimmune disease celiac disease

As listed by the trial registrant

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

Autoimmune diseases Celiac disease Gluten sensitivity

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, 29010, Spain

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