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NCT05054361: MAIT-DT1
Crosstalk Between Mucosal-Associated Invariant T (MAIT) Cells and the Gut Microbiota and Mucosa in the Development of Type 1 Diabetes in Children
trial testing MAIT cells analysis in Type1diabetes in 180 participants. Currently enrolling.
11 August 2026
Quick facts
| Lead sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 1 January 2022 |
| Primary completion | 11 August 2026 |
| Estimated completion | 14 August 2027 |
| Sites | 2 locations across France |
Drugs / interventions tested
- MAIT cells analysis
- MAIT cytokines production analysis
- Lactulose/Mannitol Test
- UGI Endoscopy
- Coxsackie virus B infection status
- Coxsackie virus B infection status
Conditions studied
- Type1diabetes — all drugs for Type1diabetes →
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France — full company profile →
Who can join
Adults 12 Months to 15, any sex, with Type1diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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 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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05054361
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05054361 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institut National de la Santé Et de la Recherche Médicale, France
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05054361.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing