Cytotoxic and regulatory roles of mucosal-associated invariant T cells in type 1 diabetes.
Ophélie Rouxel, Jennifer Da Silva, Lucie Beaudoin...
https://pubmed.ncbi.nlm.nih.gov/28991267Actively Recruiting
Age: 12Months - 15Years
All Genders
Healthy Volunteers
ID05054361
Crosstalk Between Mucosal-Associated Invariant T 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
52 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
Researchers are investigating how Mucosal-Associated Invariant T (MAIT) cells interact with the gut microbiota and gut lining in children at risk for or recently diagnosed with type 1 diabetes (T1D). The study compares three groups: children with recent onset T1D, children genetically at risk for T1D, and healthy control children. The goal is to understand changes in MAIT cells, gut health, and the presence of Coxsackie virus B that may relate to the development and progression of T1D. The study involves detailed analysis of blood samples to measure MAIT cell frequency, activation, exhaustion, and function using specialized laboratory tests. Stool samples are collected to study gut bacteria and the presence of Coxsackie virus B. Some participants undergo a gut permeability test involving sugar drinks and urine collection, while others may have duodenal biopsies taken during upper gastrointestinal endoscopy to study the gut lining and immune response. These procedures help assess gut integrity and immune markers. Participants will have samples collected at enrollment or shortly after diagnosis, including blood, stool, and possibly urine or biopsy samples. Researchers will analyze MAIT cells, gut bacteria, viral presence, and gut lining markers. The study measures how these factors relate to T1D development. Safety is monitored through medical history review and eligibility screening. Participation duration depends on enrollment timing, with assessments focused on baseline and related analyses.
CONDITIONS
Brief 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
Age: 12Months - 15Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Recent onset group: age over 12 months and under 15 years
- Recent onset group: recently diagnosed type 1 diabetes according to ISPAD criteria
- At risk group: age over 12 months and under 15 years
- At risk group: siblings of type 1 diabetic patient
- At risk group: positive for HLA DR3 and DR4
- Control subjects: age over 12 months and under 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 over 12 months and under 15 years
- Control subjects for UGI endoscopy: suspicion of celiac disease or gastritis
You will not qualify if you...
- No health care insurance
- Parents or tutors unable to sign consent
- Personal history of autoimmune 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 to anesthetic topical agents
- For recent onset endoscopy group: age below 8 years
- For UGI endoscopy control group: age below 4 years
- Cardiac or respiratory insufficiency, cardiac rhythm disorders, coagulation disease
- Treatment with anticoagulant or antiaggregant drugs
- History of allergy to anesthetic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Day of enrollment or up to 7 days after diagnosis
Participants undergo various diagnostic tests including blood and stool sample collection to analyze MAIT cells, cytokine production, Coxsackie virus B infection status, and gut microbiota composition. Some participants provide urine samples for the Lactulose-Mannitol test to assess intestinal permeability. A subset of participants undergoes upper gastrointestinal endoscopy with duodenal biopsy for gut mucosa analysis.
1 to 2 visits depending on procedures and cohort assignment
Long-term Monitoring
Duration - Up to several years until study completion
Participants are observed over time to study changes in MAIT cells, gut microbiota, and gut mucosa integrity related to the development or risk of type 1 diabetes.
Follow-up visits as per clinical needs; exact frequency varies
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
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Research Team
J
jacques beltrand, MD, PhD
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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Published Research Related To This Trial
Gut mucosa alterations and loss of segmented filamentous bacteria in type 1 diabetes are associated with inflammation rather than hyperglycaemia.
Matthieu Rouland, Lucie Beaudoin, Ophélie Rouxel...
https://pubmed.ncbi.nlm.nih.gov/33593807