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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Growth, Allergy

Intervention / Treatment
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* Other: Modilac Rose 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modilac Rose 1<br>Infant formula with partially hydrolysed rice protein | Other: Modilac Rose 1<br>* Infant formula used for non-breastfed children<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth parameters |  | 2nd, 4th and 6th months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Tolerance |  | 3 days before the 2nd and 6th months | 
| Atopic diseases (eczema atopic, asthma) |  | 2nd and 6th months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hydrolysed rice protein formula, Cow's milk protein allergy, Infant formula, Gastrointestinal tolerance