Studies immune cells, gut bacteria and gut lining in children with type 1 diabetes
Compares immune cells and gut bacteria in children at risk or newly diagnosed with diabetes.
Plain-language title generated from the registry record
Registry title: Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Key facts
- Where
- Antony and Paris, FranceSee the 2 sites
Where in France
- Hopital Prive D AntonyAntony, FranceNot yet recruiting
- Hopital Necker Enfants MaladesParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut National de la Santé Et de la Recherche Médicale, France
- Trial code
- NCT05054361
- Record updated
- 27 October 2026
- Original description
To investigate in a prospective way changes in Mucosal-Associated Invariant T (MAIT) cells frequency, phenotype and function in link with the gut microbiota, gut integrity and the presence of Coxsackie virus B in two cohorts of pediatric patients: patients with a high genetic risk of type 1 diabetes and pediatric patients with recently diagnosed T1D by comparison with control subjectsRead full original descriptionShow less
Crosstalk Between Mucosal-Associated Invariant T Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
To investigate in a prospective way changes in Mucosal-Associated Invariant T (MAIT) cells frequency, phenotype and function in link with the gut microbiota, gut integrity and the presence of Coxsackie virus B in two cohorts of pediatric patients: patients with a high genetic risk of type 1 diabetes and pediatric patients with recently diagnosed T1D by comparison with control subjects
Tasks:
1. To measure blood MAIT cells frequency, phenotype and function in the three cohorts 2. To analyze gut microbiota and the presence of Coxsackie B enterovirus (CVB) and their impact on MAIT cell function 3. To evaluate gut integrity and analyze the gut mucosa 4. To integrate all the data obtained with T1D development and evolution
Inclusion: 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: use of corticosteroids during the month before inclusion; cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease, patients treated with anticoagulant or antiaggregant drug; personal history of autoimmune disease and/or inflammatory disease except from T1D for RD and CE groups; history of allergy to anesthetic drug; age below 8 years for Recent onset-endoscopy group; age below 4 for UGI endoscopy control group; For all groups:; no health care insurance; parents or tutors unable to sign the consent; pregnant subjects; medical contraindication of anesthetic topics; For control subjects for UGI endoscopy control and Recent onset-endoscopy group:.