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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.

Key facts

Who runs it
Institut National de la Santé Et de la Recherche Médicale, France
Where
Antony and Paris, FranceSee the 2 sites
Trial code
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
Status
Recruiting
People taking part
180 people, planned
Started
14 Feb 2022
Expected to end
14 Aug 2027
Type of study
Observational, 4 groups
Treatments tested
  • MAIT cells analysis
  • MAIT cytokines production analysis
  • Lactulose/Mannitol Test
  • UGI Endoscopy
  • Coxsackie virus B infection status
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children with recently diagnosed type 1 diabetes, children at high genetic risk of type 1 diabetes, and control children without that risk.

Age
From more than 12 months to less than 15 years.
Sex
All sexes can join.
Disease stage
One group has recently diagnosed type 1 diabetes (ISPAD criteria). Another group is siblings of a child with type 1 diabetes.
Earlier treatment
No corticosteroids in the month before joining.
Biomarker or test result
At-risk group: HLA DR3 and DR4 positive. Control group: no HLA linked to high risk of type 1 diabetes and no antibodies against pancreas antigens.

Main reasons for not taking part

  • No health care insurance
  • Parents or guardians unable to sign the consent
  • Other autoimmune or inflammatory disease (except type 1 diabetes in some groups)
  • Corticosteroid use in the month before joining
  • Pregnancy

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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:

Where in France

  • Hopital Prive D AntonyAntony, FranceContact: Christine Rizk, MDNot yet recruiting
  • Hopital Necker Enfants MaladesParis, FranceContact: jacques Beltrand, MDTaking people

About the trial

What the trial wants to find out

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

Read full original descriptionShow less

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

The 4 groups in the trial

  • recent onset patients

    patients with recently diagnosed type 1 diabetes

    Treatment: MAIT cells analysis, MAIT cytokines production analysis, Lactulose/Mannitol Test, UGI Endoscopy, and Coxsackie virus B infection status

  • at risk patients

    patients with a high genetic risk type 1 diabetes

    Treatment: MAIT cells analysis, MAIT cytokines production analysis, Lactulose/Mannitol Test, and Coxsackie virus B infection status

  • control subjects

    control patients (no risk of type 1 diabetes and no diagnosed type 1 diabetes)

    Treatment: MAIT cells analysis, MAIT cytokines production analysis, Lactulose/Mannitol Test, and Coxsackie virus B infection status

  • control subjects for endoscopy

    patients without type 1 diabetes requiring UGI endoscopy for any medical reason

    Treatment: MAIT cells analysis, MAIT cytokines production analysis, UGI Endoscopy, and Coxsackie virus B infection status

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Crosstalk Between Mucosal-Associated Invariant T Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Plain-language title
Studies immune cells, gut bacteria and gut lining in children with type 1 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 October 2026