Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
NCT00929292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2009-06-29
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.
Conditions
- Growth
- Colic
Interventions
- OTHER
-
Modilac Dahlia 1
Infant formula used for non breastfed children with colic
- OTHER
-
Modilac 1
Infant formula used for non breastfed children
Sponsors & Collaborators
-
Sodilac
lead INDUSTRY
Principal Investigators
-
Christophe Dupont, PhD · Hôpital Saint Vincent de Paul
Study Design
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Weeks
- Max Age
- 3 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2008-07-31
- Completion
- 2008-07-31
Countries
- France
Study Locations
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