NCT00929292

Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic

Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Sodilac · Industry
• Sex: All
• Age: 3 Weeks – 3 Months
• Healthy volunteers: Not accepted

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 formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30. Both parents provided informed written consent.

Conditions

• Growth
• Colic

Interventions

Type	Name	Description
OTHER	Modilac Dahlia 1	Infant formula used for non breastfed children with colic
OTHER	Modilac 1	Infant formula used for non breastfed children

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2009-06-29
• Last updated: 2009-06-29

Locations

12 sites across 1 country: France