Investigating the role of immune cells and gut bacteria in type 1 diabetes in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between Mucosal-Associated Invariant T (MAIT) cells, gut microbiota, and gut integrity in pediatric patients at risk for or recently diagnosed with type 1 diabetes. It will involve measuring the frequency, phenotype, and function of MAIT cells in three cohorts: those with recent-onset type 1 diabetes, siblings at high genetic risk, and control subjects. The study will also analyze the presence of Coxsackie virus B and its impact on MAIT cell function, as well as evaluate gut mucosa integrity. Data integration will help understand the development and progression of type 1 diabetes.

Why it matters

Who can join: the full rules

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

Where it's running

• Hopital Necker enfants malades
  Paris, France Recruiting
• Hopital privé d'Antony
  Antony, France Not yet recruiting

Study contacts

• Study coordinator: jacques beltrand, MD, PhD
• Email: jacques.beltrand@aphp.fr
• Phone: +33144481545

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.