NCT00997971

Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein

Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Sodilac · Industry
• Sex: All
• Age: 1 Month
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.

Detailed description

This objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula. Parents provide informed written consent. 4 visits are forecasted in pediatric surgeries: V1(inclusion), V2 (2 months), V3 (4 months) and V4 (6 months). The last visit corresponds to the beginning of the food diversification decided by the pediatrician. Ideally it takes place at 6 months. If the food diversification starts at 4 months, then V3 and V4 constitute the same last visit.

Conditions

• Growth
• Allergy

Interventions

Type	Name	Description
OTHER	Modilac Rose 1	Infant formula used for non-breastfed children

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-10-20
• Last updated: 2009-10-20

Locations

9 sites across 1 country: France