Impact of a Fermented Infant Formula in Weaning Babies

March 6, 2009 updated by: Bledina
When mothers wanted to shift from breast milk to infant formulae, babies were randomly assigned to receive a fermented or a standard formula. Biological and clinical investigations were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of study formula. Intestinal microbiota was assessed by using culture-dependent techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

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

  • France
      • Bondues, France, 59910
        • Cabinet Médical
      • Dunkerque, France, 59240
        • Cabinet Médical
      • Lambersart, France, 59130
        • Cabinet Médical
      • Lille, France, 59000
        • Cabinet Médical
      • Lille, France, 59000
        • Hopital Saint Vincent de Paul
      • Roncq, France, 59223
        • Cabinet Médical

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

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eutrophic infants, (± 2SD), healthy, male or female, of 2 months of age (± 1 week)
  • Born at 37 weeks of amenorrhea or more
  • Exclusively breastfed since birth
  • Written informed consent given by both parents (or tutors) for study participation
  • Parents (or tutors) agreeing on the follow-up by one of the study investigators

Exclusion Criteria:

  • Infant with congenital or acquired immunodeficiency, whatever the aetiology
  • Infant with a significant metabolic, organic or bowel disease which could interfere with the results of the present study,
  • Infant with congenital and/or chromosomal malformation,
  • Infant having received antibiotic therapy within the 3 weeks before the inclusion visit
  • infant receiving a treatment susceptible to interfere with the measure of study parameters
  • Antibiotic therapy per/pre/post partum > 48 h
  • Infant needing the prescription of a specific milk (HA, without cow milk)
  • Infant in a situation which could interfere with an optimal participation to the study, or which could represent a risk for the infant, according to the investigator.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Breastfed babies
Other: Breastmilk
Exclusively breastfed babies
Other Names:
  • No other names
Active Comparator: 2
Weaning with the standard milk
Other: Standard milk
Weaning babies fed with the standard formula
Other Names:
  • No other names
Experimental: 3
Weaning with the fermented milk
Other: Fermented milk
Weaning babies fed with the fermented formula
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies
Time Frame: 2, 3 and 5 months of age
2, 3 and 5 months of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Describe the intestinal flora according to the nutrition group
Time Frame: 3 and 5 months of age
3 and 5 months of age
Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
Time Frame: 3 months of age
3 months of age
Describe the growth, according to the nutrition group
Time Frame: 3 and 5 months of age
3 and 5 months of age
Describe the milk tolerance at the weaning according to the nutrition group
Time Frame: 3 and 5 months of age
3 and 5 months of age
Describe the infection signs according to the nutrition group
Time Frame: 3 and 5 months of age
3 and 5 months of age
Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group
Time Frame: 9 months of age
9 months of age
Compare the effect on enterobacteria, clostridium and bifidobacteria of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
Time Frame: 5 months of age
5 months of age

Collaborators and Investigators

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

Sponsor

Bledina

Collaborators

MAPI

Investigators

  • Principal Investigator: Nicolas Kalach, MD, Hopital Saint Vincent de Paul

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

April 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BL009

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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