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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997971

Acronym

Rose

Enrollment

Registered

2009-10-20

Start date

2007-09-30

Completion date

2009-08-31

Last updated

2009-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Growth

Keywords

Hydrolysed rice protein formula, Cow's milk protein allergy, Infant formula, Gastrointestinal tolerance

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.

Interventions

OTHERModilac Rose 1

Infant formula used for non-breastfed children

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Growth parameters	2nd, 4th and 6th months

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026