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

Nestlé

Status

Terminated

Conditions

Healthy Full Term Infants

Treatments

Dietary Supplement: formula without synbiotics

Dietary Supplement: formula with synbiotics

Study type

Interventional

Funder types

Industry

Identifiers

NCT02031887

07.19.INF

Details and patient eligibility

About

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.

Full description

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.

Enrollment

430 patients

Sex

All

Ages

Under 3 days old

Volunteers

Accepts Healthy Volunteers

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