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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-08-31

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.

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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.

Conditions

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Growth Allergy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Modilac Rose 1

Infant formula with partially hydrolysed rice protein

Group Type EXPERIMENTAL

Modilac Rose 1

Intervention Type OTHER

Infant formula used for non-breastfed children

Interventions

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Modilac Rose 1

Infant formula used for non-breastfed children

Intervention Type OTHER

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

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No