Healthy Full Term Infants
Conditions
Keywords
starter formula, stool microbiota, infants, caesarean section delivery
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTformula with synbiotics
DIETARY_SUPPLEMENTformula without synbiotics
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 3 days, 10 days, 1 month, and 3 months of age of the infant |
| • Mean weight gain (g/day) | over 112 days |
Secondary
| Measure | Time frame |
|---|---|
| body composition by DEXA | 4 month and 12 month of life |
| Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | 10 days, 1 month, 6 weeks, 3 month and 4 month of life |
Countries
South Africa
Outcome results
None listed