Status:
ACTIVE_NOT_RECRUITING
Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity
Lead Sponsor:
Helmholtz Zentrum München
Collaborating Sponsors:
Technical University of Munich
Kinderkrankenhaus auf der Bult
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
7-6 years
Phase:
NA
Brief 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 (+...
Detailed Description
The GPPAD-04 SINT1A study will evaluate whether early, regular supplementation with a daily dose of a probiotic can reduce the risk of developing beta-cell autoimmunity in children identified by GPPAD...
Eligibility Criteria
Inclusion
- 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).-
Exclusion
- 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.
- Preterm delivery \< 36 weeks of gestation.
- Proven immunodeficiency.
- Any condition that could be associated with poor compliance.5. Diagnosis of diabetes at the time of recruitment
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2027
Estimated Enrollment :
1149 Patients enrolled
Trial Details
Trial ID
NCT04769037
Start Date
April 22 2021
End Date
October 1 2027
Last Update
December 13 2024
Active Locations (8)
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1
University Hospitals Leuven Faculty of Medicine, Catholic University of Leuven
Leuven, Belgium
2
Universitätsklinikum Carl Gustav Carus Technische Universität Dresden
Dresden, Germany
3
AUF DER BULT, Kinder- und Jugendkrankenhaus
Hanover, Germany
4
Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar
Munich, Germany