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Gut check: could your Child's microbiome predict diabetes?

NCT ID NCT05054361

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 explores how certain immune cells (MAIT cells) and gut bacteria work together in children who either have type 1 diabetes, are at high genetic risk, or are healthy. Researchers will collect blood and gut samples from 180 children to understand these interactions. The goal is to learn more about how type 1 diabetes develops, not to test a new treatment.

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.

Participants

About 180 people

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

Started

Jan 2022

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Study population: patients recently diagnosed with type 1 diabetes and patients with a high risk of type 1 diabetes

Ages

12 months to 15 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: Recent onset group * age \> 12 months and \< 15 years * recently diagnosed type 1 diabetes according ISPAD criteria At risk subjects: * age \> 12 months and \< 15 years * siblings of type 1 diabetic patient * HLA DR3 and DR4 positive Control subjects: * age \> 12 months and \< 15 years * no HLA associated with high risk type 1 diabetes * no antibodies against pancreas antigenes Control subjects for UGI endoscopy: * age \> 12 months and \< 15 years * suspicion of coeliac disease or gastritis Exclusion Criteria: For all groups: * no health care insurance * parents or tutors unable to sign the consent * personal history of autoimmune disease and/or inflammatory disease except from T1D for RD and CE groups * use of corticosteroids during the month before inclusion * pregnant subjects * medical contraindication of anesthetic topics For control subjects for UGI endoscopy control and Recent onset-endoscopy group: * age below 8 years for Recent onset-endoscopy group * age below 4 for UGI endoscopy control group * cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease, patients treated with anticoagulant or antiaggregant drug * history of allergy to anesthetic drug

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

TYPE1DIABETES

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

    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

  • Hopital Necker enfants malades

    RECRUITING

    Paris, 75015, France

  • Hopital privé d'Antony

    NOT_YET_RECRUITING

    Antony, 92160, France

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