Actively Recruiting
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Led by Institut National de la Santé Et de la Recherche Médicale, France · Updated on 2026-04-13
180
Participants Needed
2
Research Sites
293 weeks
Total Duration
On this page
Sponsors
I
Institut National de la Santé Et de la Recherche Médicale, France
Lead Sponsor
I
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recent onset group: Age greater than 12 months and less than 15 years
- Recent onset group: Recently diagnosed type 1 diabetes according to ISPAD criteria
- At risk subjects: Age greater than 12 months and less than 15 years
- At risk subjects: Siblings of type 1 diabetic patients
- At risk subjects: HLA DR3 and DR4 positive
- Control subjects: Age greater than 12 months and less than 15 years
- Control subjects: No HLA associated with high risk type 1 diabetes
- Control subjects: No antibodies against pancreas antigens
- Control subjects for UGI endoscopy: Age greater than 12 months and less than 15 years
- Control subjects for UGI endoscopy: Suspicion of coeliac disease or gastritis
You will not qualify if you...
- No health care insurance
- Parents or tutors unable to sign the consent
- Personal history of autoimmune disease and/or inflammatory disease except type 1 diabetes for recent onset and control endoscopy groups
- Use of corticosteroids during the month before inclusion
- Pregnant subjects
- Medical contraindication of anesthetic topics
- For control subjects for UGI endoscopy and recent onset endoscopy group: Age below 8 years for recent onset endoscopy group
- For control subjects for UGI endoscopy and recent onset endoscopy group: Age below 4 years for UGI endoscopy control group
- Cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease, or treatment with anticoagulant or antiaggregant drugs
- History of allergy to anesthetic drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hopital privé d'Antony
Antony, France, 92160
Not Yet Recruiting
2
Hopital Necker enfants malades
Paris, France, 75015
Actively Recruiting
Research Team
J
jacques beltrand, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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