Status:
COMPLETED
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
Lead Sponsor:
Sodilac
Conditions:
Growth
Eligibility:
All Genders
Up to 8 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and contain...
Detailed Description
This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic...
Eligibility Criteria
Inclusion
- Term health newborn infant with gestational age ranging from 37 to 42 weeks
- Eutrophic
- Non breastfed children
- Apgar score \> 5 to 7 minutes
Exclusion
- Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
- Evidence of protein cow milk allergy
- Infant presenting lactose intolerance
- Newborn whose parents did not provide informed consent
- Newborn currently participating in another trial
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00920166
Start Date
February 1 2007
End Date
March 1 2008
Last Update
June 15 2009
Active Locations (4)
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1
CHU d'Angers
Angers, France, 49933
2
CHU de Nantes
Nantes, France, 44093
3
Hôpital Saint Vincent de Paul (AP-HP)
Paris, France, 75014
4
Hôpital de la Pitié Salpétrière
Paris, France, 75651