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

January 7, 2014 updated by: Nestlé

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Bertsham, South Africa, 2013
        • Chris Hani Baragwanath Hospital
      • Johannesburg, South Africa, 2112
        • Rahima Moosa Mother and Child Hospital
    • Parktown
      • Johannesburg, Parktown, South Africa, 2000
        • Witswatersrand University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 days (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Infant starter formula with synbiotics
Dietary supplement: formula with synbiotics
ACTIVE_COMPARATOR: Infant formula without synbiotics
Dietary supplement: formula without synbiotics

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 3 days, 10 days, 1 month, and 3 months of age of the infant
3 days, 10 days, 1 month, and 3 months of age of the infant
• Mean weight gain (g/day)
Time Frame: over 112 days
over 112 days

Secondary Outcome Measures

Outcome Measure
Time Frame
body composition by DEXA
Time Frame: 4 month and 12 month of life
4 month and 12 month of life
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Time Frame: 10 days, 1 month, 6 weeks, 3 month and 4 month of life
10 days, 1 month, 6 weeks, 3 month and 4 month of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Peter A Cooper, Witswatersrand University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (ESTIMATE)

January 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 9, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07.19.INF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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