Clinical trial NCT00858026: Impact of a Fermented Infant Formula in Weaning Babies
Official title: Impact of a Fermented Infant Formula in Weaning Babies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning
Keywords: weaning
breastfeeding
infant formula
fermented formula
Lead sponsor: Bledina
Sponsor class: INDUSTRY
Collaborators: name: MAPI
First posted: 2009-03-09
Enrollment: 91
Sex: ALL
Minimum age (years): 54
Maximum age (years): 68
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the impact of a fermented infant formula on the intestinal microbiota in weaning babies
timeFrame: 2, 3 and 5 months of age
Secondary outcomes:
measure: Describe the intestinal flora according to the nutrition group
timeFrame: 3 and 5 months of age
measure: Compare the effect on enterobacteria and clostridium of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
timeFrame: 3 months of age
measure: Describe the growth, according to the nutrition group
timeFrame: 3 and 5 months of age
measure: Describe the milk tolerance at the weaning according to the nutrition group
timeFrame: 3 and 5 months of age
measure: Describe the infection signs according to the nutrition group
timeFrame: 3 and 5 months of age
measure: Describe weight and height, current alimentation and potential infectious diseases since the visit at 5 months of age, according to the nutrition group
timeFrame: 9 months of age
measure: Compare the effect on enterobacteria, clostridium and bifidobacteria of a fermented formula vs. a standard formula toward the pursuit of breastfeeding
timeFrame: 5 months of age
Other outcomes:
Locations:
city: Bondues
country: France
facility: Cabinet médical
city: Dunkerque
country: France
facility: Cabinet médical
city: Lambersart
country: France
facility: Cabinet medical
city: Lille
country: France
facility: Cabinet médical
city: Lille
country: France
facility: Hôpital saint Vincent de Paul
city: Roncq
country: France
facility: Cabinet médical
Study officials:
affiliation: Hopital Saint Vincent de Paul
name: Nicolas Kalach, MD
role: PRINCIPAL_INVESTIGATOR
References: