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

Crosstalk Between Mucosal-Associated Invariant T Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children

This study is trying to see how immune cells and gut bacteria are connected to type 1 diabetes in children who are newly diagnosed or at high risk.

Quick facts

• Study type: Observational
• Enrollment: 180 (estimated)
• Ages: 12 Months to 15 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 2 sites (Antony and 1 other locations)
• Trial ID: NCT05054361 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include children aged 12 months to 15 years who are either recently diagnosed with type 1 diabetes or are siblings of type 1 diabetic patients with specific genetic markers.

Not a fit: Patients with a personal history of autoimmune diseases other than type 1 diabetes or those who have used corticosteroids in the month prior to inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new insights into the immune mechanisms involved in type 1 diabetes, potentially guiding preventive strategies or treatments.

How similar studies have performed: While the specific approach of this study is novel, similar studies investigating the role of immune cells and gut microbiota in autoimmune diseases have shown promising results.

Eligibility criteria

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 this trial is running

Antony and 1 other locations

• Hopital privé d'Antony — Antony, France (Not_yet_recruiting)
• Hopital Necker enfants malades — Paris, France (Recruiting)

Study contacts

• Study coordinator: jacques beltrand, MD, PhD

Conditions Type1diabetes