Status:
COMPLETED
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
Lead Sponsor:
Sodilac
Conditions:
Growth
Colic
Eligibility:
All Genders
3-3 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.
Detailed Description
This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formu...
Eligibility Criteria
Inclusion
- Healthy term infants with a gestational age ranging from 37 to 42 weeks
- Non breastfed children
- Infants with normal growth
- Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
- These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
- Apgar score \> 5 to 7 minutes
Exclusion
- Infants with severe regurgitations
- Newborn currently participating in another trial
- Infants presenting a metabolic, nervous or organic disease able to interfere with the study
- Infants presenting lactose intolerance
- Evidence of protein cow's milk allergy
- Mother who wants to keep breasfeeding
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00929292
Start Date
November 1 2006
End Date
July 1 2008
Last Update
June 29 2009
Active Locations (12)
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1
Dr Francine Gressin-Cohen
Antony, France, 92160
2
Hôpital privé d'Antony
Antony, France, 92166
3
Hôpital Robert Ballanger
Aulnay-sous-Bois, France, 93602
4
Dr Brigitte Pacault
Boulogne-Billancourt, France, 92100