Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Full Term Infants
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 430
- Locations
- 3
- Primary Endpoint
- 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
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Time Frame: 3 days, 10 days, 1 month, and 3 months of age of the infant
• Mean weight gain (g/day)
Time Frame: over 112 days
Secondary Outcomes
- 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)