NCT04769037Active, not recruiting
Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
"SINT1A" - Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity - A Study of the Global Platform for the Prevention of Autoimmune Diabetes ("GPPAD")
Source: ClinicalTrials.gov · Last updated 13 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1149 (actual)
- First submitted
- 19 Feb 2021
- Start date
- 22 Apr 2021
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Helmholtz Zentrum München
- Diseases
- Type 1 diabetes
- NCT number
- NCT04769037
What you commit to
- Study type: Interventional
- Participants enrolled: 1149
- From 22 Apr 2021 to the primary completion date, 31 Oct 2027
- 8 sites in 5 countries
- 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
- 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.
Other illness
- Any condition that could be associated with poor compliance.5. Diagnosis of diabetes at the time of recruitment
Other
- Preterm delivery \< 36 weeks of gestation.
- Proven immunodeficiency.
Who the study is looking for
- 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.
- A 10% or higher genetic risk to develop multiple beta-cell autoantibodies by age 6 years:
- 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.
- 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.
- Written informed consent signed by the custodial parent(s).-
Age in the registry: 7 days to 6 weeks · Sex: All · Accepts healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Leuven, Faculty of Medicine, Catholic University of Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Universitätsklinikum Carl Gustav Carus Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| AUF DER BULT, Kinder- und Jugendkrankenhaus Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar Coordinator of this site? Confirm its status | Munich | Germany | Unknown status |
| University Department of Paediatrics, Cambridge Biomedical Campus Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Royal Victoria Infirmary, Newcastle upon Tyne Coordinator of this site? Confirm its status | Newcastle | United Kingdom | Unknown status |
| Department of Paediatrics Medical University of Warsaw Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Lund University, Skane University Hospital SUS Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.