Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery

Overview

The primary objectives of this trial are: * to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product * to investigate whether there is equivalence in growth between the four different groups of infant described above.

The primary objectives of this trial are: * to show differences in the colonization of the gastrointestinal tract with the bacteria Bifidobacterium sp. between infants born by normal or caesarean delivery, fed with the test or a control product * to investigate whether there is equivalence in growth between the four different groups of infant described above. Design: This is a controlled, double blind, randomized, multi center, clinical trial of 4 groups in parallel. Two groups of infants (born from normal or caesarean delivery) will each consume one of 2 milk formulae. Number of patients (to be enrolled / to be analyzed): Approximately 450 / 240 Stratification will be done by gender and delivery mode. Description of subjects and main criteria for inclusion: Healthy full term infants born from HIV positive mothers who have elected to feed their child exclusively with a milk formula from birth. Children born after normal or caesarean delivery will be considered separately.

Conditions

Interventions

Eligibility

Locations (3)

Outcomes