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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 15
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
France
Hopital privé d'Antony
NOT_YET_RECRUITING
Antony
Hopital Necker enfants malades
RECRUITING
Paris
Contact Information
Primary
jacques beltrand, MD, PhD
jacques.beltrand@aphp.fr
+33144481545
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2027-08-14
Participants
Target number of participants: 180
Treatments
recent onset patients
patients with recently diagnosed type 1 diabetes
at risk patients
patients with a high genetic risk type 1 diabetes
control subjects
control patients (no risk of type 1 diabetes and no diagnosed type 1 diabetes)
control subjects for endoscopy
patients without type 1 diabetes requiring UGI endoscopy for any medical reason
Related Therapeutic Areas
Sponsors
Leads: Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, Assistance Publique - Hôpitaux de Paris, Tampere University

This content was sourced from clinicaltrials.gov