NCT00920166

Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants

Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Sodilac · Industry
• Sex: All
• Age: 8 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Growth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pétunia 1	Infant formula used for non breastfed children
DIETARY_SUPPLEMENT	Regular formula	Infant formula used for non breastfed children

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2009-06-15
• Last updated: 2009-06-15

Locations

4 sites across 1 country: France