Healthy Full Term Infants Clinical Trial
Official title:
Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science