Clinical Trials in the UK / NCT04769037
Active, not recruiting
Not applicable
Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
NCT04769037 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Diabetes Mellitus, Type 1
Investigational drug(s) / intervention(s)
B. infantisPlacebo
B. infantis: Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day
Placebo: Lactose identical in appearance and taste to the active supplement
Study summary
Investigator initiated, randomised, placebo-controlled, double-blind, multi-centre primary intervention study to assess whether daily administration of B. infantis EVC001 from age 7 days to 6 weeks (+14 days) until age 12 months (+ 14 days) to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.
Eligibility
Inclusion Criteria:
1. Infants between the ages of 7 days and 6 weeks (+14 days in case of illness or COVID-19 related issues or unexpected delay in result reporting) at the time of randomisation.
2. A 10% or higher genetic risk to develop multiple beta-cell autoantibodies by age 6 years:
1. For infants without a first-degree family history of type 1 diabetes, high genetic risk is defined as a DR3/DR4-DQ8 or DR4-DQ8/DR4-DQ8 genotype and a genetic risk score that is in the upper 25th centile (\>14.4) or a DR3/DR4-DQ8 genotype with a GRS between the upper 50th (14.0) and 25th centile and a GG genotype at the rs3763305 SNP. These represent around 1% of all newborns.
2. For infants with a first-degree family history of type 1 diabetes, high genetic risk is defined as having HLA DR4 and DQ8, and none of the following protective alleles: DRB1\*1501, DQB1\*0503, DRB1\*1303. These represent around 30% of infants with a first-degree family history of T1D.
3. Written informed consent signed by the custodial parent(s).-
Exclusion Criteria:
1. Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the Investigators.
2. Preterm delivery \< 36 weeks of gestation.
3. Proven immunodeficiency.
4. Any condition that could be associated with poor compliance.5. Diagnosis of diabetes at the time of recruitment
Primary outcome measure(s)
- Persistent confirmed multiple beta-cell autoantibodies — Through study completion, up to 6.5 years
Persistent confirmed multiple beta-cell autoantibodies is defined as confirmed IAA, confirmed GADA, confirmed IA-2A, or confirmed ZnT8A in two consecutive samples, AND a confirmed second antibody from these four antibodies in one sample. The primary outcome is the elapsed time from the random treatment assignment to the first confirmed autoantibody positive sample used in defining the persistent confirmed multiple beta-cell autoantibody positive status. Diabetes in the absence of multiple beta-cell autoantibodies is also considered as a primary outcome endpoint, and in this case, the date of diagnosis is the time of the end point.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospitals Leuven Faculty of Medicine, Catholic University of Leuven | Leuven | Belgium | |
| Universitätsklinikum Carl Gustav Carus Technische Universität Dresden | Dresden | Germany | |
| AUF DER BULT, Kinder- und Jugendkrankenhaus | Hanover | Germany | |
| Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar | Munich | Germany | |
| Department of Paediatrics Medical University of Warsaw | Warsaw | Poland | |
| Lund University, Skane University Hospital SUS | Malmö | Sweden | |
| University Department of Paediatrics, Cambridge Biomedical Campus | Cambridge | United Kingdom | |
| Royal Victoria Infirmary, Newcastle upon Tyne | Newcastle | United Kingdom |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04769037 on ClinicalTrials.gov ↗ ← All trials in the UK