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

Phase 3

Completed

• Conditions: Growth
• Interventions: Dietary Supplement: Pétunia 1; Dietary Supplement: Regular formula

• Registration Number: NCT00920166
• Lead Sponsor: Sodilac

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.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Last Update Submitted: 2009-06-12
• Study First Posted: 2009-06-15
• Last Update Posted: 2009-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modilac Pétunia 1	Pétunia 1	Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
Modilac 1	Regular formula	Regular milk

Primary Outcome Measures

Name	Time	Method
Growth Parameters	1, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

CHU d'Angers; 🇫🇷 Angers, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Saint Vincent de Paul (AP-HP); 🇫🇷 Paris, France

Hôpital de la Pitié Salpétrière; 🇫🇷 Paris, France