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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modilac Rose 1 | Experimental | Infant formula with partially hydrolysed rice protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modilac Rose 1 | Other | Infant formula used for non-breastfed children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth parameters | 2nd, 4th and 6th months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Tolerance | 3 days before the 2nd and 6th months | |
| Atopic diseases (eczema atopic, asthma) | 2nd and 6th months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Girardet, PhD | Hôpital d'enfants Armand Trousseau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix-les-Bains | 73100 | France | ||||
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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| Asnières |
| 92600 |
| France |
| Besançon | 25000 | France |
| Boulogne-Billancourt | 92100 | France |
| Caen | 14000 | France |
| Écully | 69130 | France |
| Lyon | 69005 | France |
| Meaux | 77100 | France |
| Saint-Priest-en-Jarez | 42270 | France |