Clinical trial NCT02031887: Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
Official title: Effect of a Starter Formula With Synbiotics on Stool Microbiota in Infants After Normal or Caesarean Section Delivery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Full Term Infants
Keywords: starter formula
stool microbiota
infants
caesarean section delivery
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 430
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 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
timeFrame: 3 days, 10 days, 1 month, and 3 months of age of the infant
measure: • Mean weight gain (g/day)
timeFrame: over 112 days
Secondary outcomes:
measure: body composition by DEXA
timeFrame: 4 month and 12 month of life
measure: Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
timeFrame: 10 days, 1 month, 6 weeks, 3 month and 4 month of life
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Witswatersrand University
state: Parktown
city: Bertsham
country: South Africa
facility: Chris Hani Baragwanath Hospital
city: Johannesburg
country: South Africa
facility: Rahima Moosa Mother and Child Hospital
Study officials:
affiliation: Witswatersrand University
name: Peter A Cooper
role: PRINCIPAL_INVESTIGATOR
References: