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

Launched by INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE, FRANCE · Sep 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the role of special immune cells called Mucosal-Associated Invariant T (MAIT) cells in children and how they interact with gut bacteria and the gut lining in relation to type 1 diabetes (T1D). Researchers want to understand how these cells change in children who are at high risk for T1D or have recently been diagnosed with it, compared to children who do not have a high risk of developing this condition. They will measure the frequency and function of MAIT cells in the blood, analyze gut bacteria, and assess the overall health of the gut.

To be part of this study, children must be between 1 and 15 years old. Those recently diagnosed with T1D, as well as siblings of T1D patients who are at high genetic risk, can participate. Control subjects who do not have a high risk for T1D are also welcome. Participants will undergo blood tests and gut assessments, and all data collected will help researchers better understand how T1D develops. It's important to know that certain health conditions or medications may prevent someone from joining the study, so it's crucial to discuss eligibility with a healthcare provider.

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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