Impact of a Fermented Infant Formula in Weaning Babies - Full Text View

Sponsors and Collaborators:	Bledina MAPI
Information provided by:	Bledina
ClinicalTrials.gov Identifier:	NCT00858026

Purpose

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.

Condition	Intervention
Weaning	Other: Breastmilk Other: Standard milk Other: Fermented milk

MedlinePlus related topics: Breast Feeding Infant and Toddler Nutrition

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Impact of a Fermented Infant Formula in Weaning Babies

Further study details as provided by Bledina:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Describe the intestinal flora according to the nutrition group [ Time Frame: 3 and 5 months of age ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Describe the growth, according to the nutrition group [ Time Frame: 3 and 5 months of age ] [ Designated as safety issue: No ]
Describe the milk tolerance at the weaning according to the nutrition group [ Time Frame: 3 and 5 months of age ] [ Designated as safety issue: No ]
Describe the infection signs according to the nutrition group [ Time Frame: 3 and 5 months of age ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	April 2006
Study Completion Date:	June 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Breastfed babies	Other: Breastmilk Exclusively breastfed babies
2: Active Comparator Weaning with the standard milk	Other: Standard milk Weaning babies fed with the standard formula
3: Experimental Weaning with the fermented milk	Other: Fermented milk Weaning babies fed with the fermented formula

Eligibility

Ages Eligible for Study:	54 Days to 68 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858026

Locations

France
Hôpital saint Vincent de Paul
Lille, France, 59000
Cabinet médical
Bondues, France, 59910
Cabinet médical
Roncq, France, 59223
Cabinet medical
Lambersart, France, 59130
Cabinet médical
Dunkerque, France, 59240
Cabinet médical
Lille, France, 59000

Sponsors and Collaborators

Bledina

MAPI

Investigators

Principal Investigator:

Nicolas Kalach, MD

Hopital Saint Vincent de Paul

More Information

No publications provided

Responsible Party:	Bledina ( Valérie Brenas )
Study ID Numbers:	BL009
Study First Received:	March 6, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858026 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Bledina:

weaning
breastfeeding
infant formula
fermented formula

ClinicalTrials.gov processed this record on May 06, 2009