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

Phase 3

Completed

• Conditions: Growth; Allergy
• Interventions: Other: Modilac Rose 1

• Registration Number: NCT00997971
• Lead Sponsor: Sodilac

Brief 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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-09-14
• Status Verified: 2009-10
• Study First Submitted QC: 2009-10-19
• Last Update Submitted: 2009-10-19
• Study First Posted: 2009-10-20
• Last Update Posted: 2009-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Term health infants with gestational age ranging from 37 to 42 weeks
• Infants less than 1 month old
• Non breastfed children at the inclusion
• Growth parameter normal
• Apgar score > 5 to 7 minutes
• Change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy
• Absence of metabolic, nervous or digestive troubles
• Absence of digestive haemorrhage, apnea or dizzy turn

Exclusion Criteria

• Partial breastfed children
• Infants presenting a cow's milk protein allergy
• Infants currently participating in another trial
• Infants presenting an organic disease involving medicinal or surgical treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modilac Rose 1	Modilac Rose 1	Infant formula with partially hydrolysed rice protein

Primary Outcome Measures

Name	Time	Method
Growth parameters	2nd, 4th and 6th months

Secondary Outcome Measures

Name	Time	Method
Clinical Tolerance	3 days before the 2nd and 6th months
Atopic diseases (eczema atopic, asthma)	2nd and 6th months