Safety of Bifidobacterium Breve PS1 for Infants
Safety of Bifidobacterium Breve PS1 for Infants
NCT ID: NCT05973812 Phase: NA Status: COMPLETED Enrollment: 80 Completion: 2015-03-12
Conditions
Infant Development, Safety Issues
Interventions
Infant formula supplemented with Bifidobacterium breve PS1, Infant formula NOT supplemented with Bifidobacterium breve PS1
Summary
The objective of this work was the characterization of the probiotic potential of Bifidobacterium breve PS1, a strain originally isolated from human milk. Subsequently, its safety and tolerance were evaluated in a trial including healthy, formula-fed 3-months-old infants. A total of 187 infants were randomized into two groups: probiotic group (PG) and control group (CG). Both groups received the same infant formula but, in the case of the PG, it was supplemented with the strain. A total of 160 infants (80 per group) completed the three months of intervention.
Primary Outcome
Weight gain