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

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,149

Participants

Timeline

Start Date

April 22, 2021

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2027

Conditions
Diabetes Mellitus, Type 1
Interventions
DIETARY_SUPPLEMENT

B. infantis

Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day

DIETARY_SUPPLEMENT

Placebo

Lactose identical in appearance and taste to the active supplement

Trial Locations (8)

Unknown

University Hospitals Leuven Faculty of Medicine, Catholic University of Leuven, Leuven

Universitätsklinikum Carl Gustav Carus Technische Universität Dresden, Dresden

AUF DER BULT, Kinder- und Jugendkrankenhaus, Hanover

Institute of Diabetes Research, Helmholtz Zentrum Munich, Germany, and Forschergruppe Diabetes, Technical University Munich (TUM), School of Medicine, Klinikum rechts der Isar, Munich

Department of Paediatrics Medical University of Warsaw, Warsaw

Lund University, Skane University Hospital SUS, Malmo

University Department of Paediatrics, Cambridge Biomedical Campus, Cambridge

Royal Victoria Infirmary, Newcastle upon Tyne, Newcastle

All Listed Sponsors
collaborator

Technical University of Munich

OTHER

collaborator

Kinderkrankenhaus auf der Bult

OTHER

collaborator

University Hospital Carl Gustav Carus

OTHER

collaborator

Skane University Hospital

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

Medical University of Warsaw

OTHER

collaborator

Cambridge Biomedical Campus, Cambridge, UK

UNKNOWN

collaborator

Royal Victoria Infirmary, Newcastle upon Tyne, UK

UNKNOWN

lead

Helmholtz Zentrum München

INDUSTRY