The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial

NARecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

June 10, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2043

Conditions
HealthyHealthy Nutrition
Interventions
DIETARY_SUPPLEMENT

B. infantis

1000 newborn children are randomized 50/50 to receive either B. infanits or placebo in a dietary supplement, for daily oral administration in three weeks from 7 days of age.

DIETARY_SUPPLEMENT

Placebo

Identical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age.

Trial Locations (2)

7400

RECRUITING

Regional Hospital Gødstrup, Herning

8700

RECRUITING

Regional Hospital Horsens, Horsens

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Gødstrup Hospital

OTHER

collaborator

Regionshospitalet Horsens

OTHER

collaborator

Technical University of Denmark

OTHER

collaborator

Statens Serum Institut

OTHER

collaborator

University of Copenhagen

OTHER

lead

University of Aarhus

OTHER