GPPAD-04-SINT1A
Research type
Research Study
Full title
Supplementation with B. infantis for mitigation of type 1 Diabetes autoimmunity
IRAS ID
298795
Contact name
Catherine Owen
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 31 days
Research 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. Enrolled participants will start intervention from earliest age of 7 days to 6 weeks (+14 days) for a period of 10 up to 12 months (until age 12 months +14 days). Participants will be followed until completion of the study for a period of 3.5 to 6.5 years at last follow-up visit. Visits will be 6 monthly whilst on the supplement and then annually thereafter. Participants who develop beta-cell autoantibodies will remain in the study and will be followed according to protocol to assess the secondary outcomes until completion of the study or until diabetes development.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0180
Date of REC Opinion
18 Nov 2021
REC opinion
Further Information Favourable Opinion