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

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.

Inclusion Criteria:

• Healthy newborn infant from HIV positive mother
• Full term infant (more or equal to 37 weeks gestation; less or equal to 42 weeks gestation)
• Age of infant 3 days at the time of enrollment
• Birth weight between 2500 and 4500 grams
• Singleton birth
• The infant's mother has elected to feed their child exclusively with a milk formula from birth
• Informed consent from the parent or legal guardian

Exclusion Criteria:

• Congenital illness or malformation that may affect normal growth
• Significant pre-natal and / or post-natal disease
• Newborns who have received antibiotics during the first 3 days of life
• Newborns whose parents / caregivers cannot be expected to comply with the study protocol
• Newborns currently participating in another clinical trial