Clinical Trials Directory

Trials / Terminated

TerminatedNCT02031887

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
430 (actual)
Sponsor
Société des Produits Nestlé (SPN) · Industry
Sex
All
Age
3 Days
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTformula with synbiotics
DIETARY_SUPPLEMENTformula without synbiotics

Timeline

Start date
2008-10-01
Primary completion
2013-02-01
Completion
2013-10-01
First posted
2014-01-09
Last updated
2014-01-09

Locations

3 sites across 1 country: South Africa

Source: ClinicalTrials.gov record NCT02031887. Inclusion in this directory is not an endorsement.