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

NCT02031887 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2014-01-09

No results posted yet for this study

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.

Conditions

  • Healthy Full Term Infants

Interventions

DIETARY_SUPPLEMENT

formula with synbiotics

DIETARY_SUPPLEMENT

formula without synbiotics

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Peter A Cooper · Witswatersrand University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-02-28
Completion
2013-10-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02031887 on ClinicalTrials.gov