Impact of a Fermented Infant Formula in Weaning Babies

Bledina

Status

Completed

Conditions

Weaning

Treatments

Other: Breastmilk

Other: Fermented milk

Other: Standard milk

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT00858026

BL009

Details and patient eligibility

About

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.

Enrollment

91 patients

Sex

All

Ages

54 to 68 days old

Volunteers

No Healthy Volunteers

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.