NCT05054361Recruiting
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Crosstalk Between Mucosal-Associated Invariant T Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 8 Jun 2021
- Start date
- 14 Feb 2022
- Primary completion date
- 14 Aug 2027
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Diseases
- Type 1 diabetes
- NCT number
- NCT05054361
What you commit to
- Study type: Observational
- Planned participants: 180
- From 14 Feb 2022 to the primary completion date, 14 Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of corticosteroids during the month before inclusion
- cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease, patients treated with anticoagulant or antiaggregant drug
Other illness
- personal history of autoimmune disease and/or inflammatory disease except from T1D for RD and CE groups
- history of allergy to anesthetic drug
Age
- age below 8 years for Recent onset-endoscopy group
- age below 4 for UGI endoscopy control group
Other
- 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:
Who the study is looking for
- 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
Age in the registry: 12 months to 15 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Prive D Antony Coordinator of this site? Confirm its status | Antony | France | Not yet recruiting |
| Hopital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.