Status:
COMPLETED
Impact of a Fermented Infant Formula in Weaning Babies
Lead Sponsor:
Bledina
Collaborating Sponsors:
MAPI
Conditions:
Weaning
Eligibility:
All Genders
54-68 years
Phase:
NA
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 ba...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00858026
Start Date
April 1 2006
End Date
June 1 2008
Last Update
March 9 2009
Active Locations (6)
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1
Cabinet médical
Bondues, France, 59910
2
Cabinet médical
Dunkirk, France, 59240
3
Cabinet medical
Lambersart, France, 59130
4
Cabinet médical
Lille, France, 59000