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

Sodilac

Status and phase

Completed

Phase 3

Conditions

Growth

Treatments

Dietary Supplement: Pétunia 1

Dietary Supplement: Regular formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT00920166

PET-CL3-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Ages

Under 8 days old

Volunteers

No Healthy Volunteers

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