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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


NCT number NCT00997971
Study type Interventional
Source Sodilac
Contact
Status Completed
Phase Phase 3
Start date September 2007
Completion date August 2009

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