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The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
This prospective, randomized, double blind, controlled study evaluated the safety and effect on growth and tolerance to an infant formula supplemented with alpha-lactalbumin and containing a symbiotic, in term infants.
Term infants with a gestational age ranging from 37 to 42 weeks and whose parents chose formula feeding were enrolled during their first eight days of life.
Both parents provided informed written consent. Infants were randomly assigned to receive either the new test formula or a control, a regular formula adapted for term infants (Modilac®1). The control formula is formulated to meet the nutritional needs of infants.
For each neonates, neonatal parameters were collected.
5 visits took place : V1 (inclusion), V2 (randomization), V3 (1 month), V4 (3 months) and V5 (6 months). During each visit, the investigator filled in observational book the anthropometric parameters (weight, height, head circumference, BMI) and pieces of information collected 3 days before by the parents (gastrointestinal tolerance parameters, daily infant behaviour and milk consumption). Global parents' contentment was evaluated as well.
In two investigation centers, at the end of the 6th month, immuno-allergic test was realised.
Stools were collected at the end of the first and sixth month from diapers, for microbiological analysis and measurements of faecal inflammatory markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modilac Pétunia 1 | Experimental | Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic |
|
| Modilac 1 | Active Comparator | Regular milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pétunia 1 | Dietary Supplement | Infant formula used for non breastfed children |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth Parameters | 1, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitization or allergy | 1, 3 and 6 months | |
| Atopic diseases (eczema atopic, asthma, allergic rhinitis) | 1, 3 and 6 months | |
| Describe the intestinal flora according to the nutrition group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Christophe Rozé, PhD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | 49933 | France | |||
| CHU de Nantes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22079177 | Derived | Roze JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An alpha-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Regular formula | Dietary Supplement | Infant formula used for non breastfed children |
|
|
| 1 and 6 months |
| Clinical Tolerance | 1 and 6 months |
| Nantes |
| 44093 |
| France |
| Hôpital Saint Vincent de Paul (AP-HP) | Paris | 75014 | France |
| Hôpital de la Pitié Salpétrière | Paris | 75651 | France |