Impact of a Fermented Infant Formula in Weaning Babies

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

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Breastfed babies

Group Type OTHER

Breastmilk

Intervention Type OTHER

Exclusively breastfed babies

2

Weaning with the standard milk

Group Type ACTIVE_COMPARATOR

Standard milk

Intervention Type OTHER

Weaning babies fed with the standard formula

3

Weaning with the fermented milk

Group Type EXPERIMENTAL

Fermented milk

Intervention Type OTHER

Weaning babies fed with the fermented formula

Interventions

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Breastmilk

Exclusively breastfed babies

Intervention Type OTHER

Standard milk

Weaning babies fed with the standard formula

Intervention Type OTHER

Fermented milk

Weaning babies fed with the fermented formula

Intervention Type OTHER

Other Intervention Names

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No other names No other names No other names

Eligibility Criteria

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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.

Minimum Eligible Age

54 Days

Maximum Eligible Age

68 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No