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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Full Term Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Infant starter formula with synbiotics

Group Type EXPERIMENTAL

formula with synbiotics

Intervention Type DIETARY_SUPPLEMENT

Infant formula without synbiotics

Group Type ACTIVE_COMPARATOR

formula without synbiotics

Intervention Type DIETARY_SUPPLEMENT

Interventions

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formula with synbiotics

Intervention Type DIETARY_SUPPLEMENT

formula without synbiotics

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes