Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants (Pétunia)
Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Angers, France, 49933
- CHU d'Angers
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Nantes, France, 44093
- CHU de Nantes
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Paris, France, 75651
- Hopital de La Pitie Salpetriere
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Paris, France, 75014
- Hôpital Saint Vincent de Paul (AP-HP)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Term health newborn infant with gestational age ranging from 37 to 42 weeks
- Eutrophic
- Non breastfed children
- Apgar score > 5 to 7 minutes
Exclusion Criteria:
- Infant presenting a metabolic, nervous, digestive or organic disease able to interfere with study
- Evidence of protein cow milk allergy
- Infant presenting lactose intolerance
- Newborn whose parents did not provide informed consent
- Newborn currently participating in another trial
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Modilac Pétunia 1
Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
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Infant formula used for non breastfed children
Autres noms:
|
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Comparateur actif: Modilac 1
Regular milk
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Infant formula used for non breastfed children
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Growth Parameters
Délai: 1, 3 and 6 months
|
1, 3 and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Sensitization or allergy
Délai: 1, 3 and 6 months
|
1, 3 and 6 months
|
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Atopic diseases (eczema atopic, asthma, allergic rhinitis)
Délai: 1, 3 and 6 months
|
1, 3 and 6 months
|
|
Describe the intestinal flora according to the nutrition group
Délai: 1 and 6 months
|
1 and 6 months
|
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Clinical Tolerance
Délai: 1 and 6 months
|
1 and 6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jean Christophe Rozé, PhD, CHU de Nantes
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- PET-CL3-001
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