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Supplementation With B. Infantis for Mitigation of Type 1 Diabetes Autoimmunity

Study acronym: SINT1A
StatusActive, Not Recruiting
PhaseNot applicable
Started2021-04-22
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 7 times since 2021-02-23; most recent filed 2024-12-12. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2024-12-12
Amendment Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
2023-09-21
Amendment Study Status v6
2022-11-08
Amendment Study Status, Contacts/Locations v5
2021-09-29
Amendment Study Status, IPDSharing v4
2021-08-31
Amendment Study Status, Study Description, Contacts/Locations v3
2021-08-09
Amendment Study Status, Contacts/Locations v2
2021-05-20
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2021-02-23
Original filing
Trial Details
NCT Number NCT04769037
Lead Sponsor Helmholtz Zentrum München
Collaborators: Technical University of Munich, Kinderkrankenhaus auf der Bult, University Hospital Carl Gustav Carus, Skane University Hospital, Universitaire Ziekenhuizen KU Leuven, Medical University of Warsaw, Cambridge Biomedical Campus, Cambridge, UK, Royal Victoria Infirmary, Newcastle upon Tyne, UK
Conditions Diabetes Mellitus, Type 1
Enrollment 1,149 participants
Start Date 2021-04-22
Primary Completion 2027-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2024-12-13