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Impact of a Fermented Infant Formula in Weaning Babies

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ClinicalTrials.gov Identifier: NCT00858026
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : March 9, 2009
Sponsor:
Collaborator:
MAPI
Information provided by:
Bledina

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.

Condition or disease Intervention/treatment Phase
Weaning Other: Breastmilk Other: Standard milk Other: Fermented milk Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Impact of a Fermented Infant Formula in Weaning Babies
Study Start Date : April 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Describe the intestinal flora according to the nutrition group [ Time Frame: 3 and 5 months of age ]
  2. 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 ]
  3. Describe the growth, according to the nutrition group [ Time Frame: 3 and 5 months of age ]
  4. Describe the milk tolerance at the weaning according to the nutrition group [ Time Frame: 3 and 5 months of age ]
  5. Describe the infection signs according to the nutrition group [ Time Frame: 3 and 5 months of age ]
  6. 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 ]
  7. 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 ]


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Ages Eligible for Study:   54 Days to 68 Days   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858026


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

Responsible Party: Valérie Brenas, Bledina
ClinicalTrials.gov Identifier: NCT00858026     History of Changes
Other Study ID Numbers: BL009
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

Keywords provided by Bledina:
weaning
breastfeeding
infant formula
fermented formula