Allergy Clinical Trial
Official title:
Phase 3 Safety Study of a Partially Hydrolyzed Rice Protein Formula in Healthy Infants
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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