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Impact of a Fermented Infant Formula in Weaning Babies

This study has been completed.
Sponsor:
Collaborator:
MAPI
Information provided by:
Bledina
ClinicalTrials.gov Identifier:
NCT00858026
First received: March 6, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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
Other Name: No other names
Active Comparator: 2
Weaning with the standard milk
 Other: Standard milk
Weaning babies fed with the standard formula
Other Name: No other names
Experimental: 3
Weaning with the fermented milk
 Other: Fermented milk
Weaning babies fed with the fermented formula
Other Name: No other names

  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
Cabinet médical
Bondues, France, 59910
Cabinet médical
Dunkerque, France, 59240
Cabinet medical
Lambersart, France, 59130
Hôpital saint Vincent de Paul
Lille, France, 59000
Cabinet médical
Lille, France, 59000
Cabinet médical
Roncq, France, 59223
Sponsors and Collaborators
Bledina
MAPI
Investigators
Principal Investigator: Nicolas Kalach, MD Hopital Saint Vincent de Paul
  More Information

No publications provided

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

Keywords provided by Bledina:
weaning
breastfeeding
infant formula
fermented formula

ClinicalTrials.gov processed this record on May 16, 2013