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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Growth

Intervention / Treatment
-----------------
* Dietary Supplement: Pétunia 1
* Dietary Supplement: Regular formula


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 8 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modilac Pétunia 1<br>Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic | Dietary Supplement: Pétunia 1<br>* Infant formula used for non breastfed children<br>* Other names: Modilac Pétunia 1;|
| Active Comparator: Modilac 1<br>Regular milk | Dietary Supplement: Regular formula<br>* Infant formula used for non breastfed children<br>* Other names: Modilac 1;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth Parameters |  | 1, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 1 and 6 months | 
| Clinical Tolerance |  | 1 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infant formula, Alpha-lactalbumin, Symbiotic, Allergy, Gastrointestinal tolerance, Bacterial colonization, Faecal IgA analysis