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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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

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Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Modilac Pétunia 1

Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic

Group Type EXPERIMENTAL

Pétunia 1

Intervention Type DIETARY_SUPPLEMENT

Infant formula used for non breastfed children

Modilac 1

Regular milk

Group Type ACTIVE_COMPARATOR

Regular formula

Intervention Type DIETARY_SUPPLEMENT

Infant formula used for non breastfed children

Interventions

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Pétunia 1

Infant formula used for non breastfed children

Intervention Type DIETARY_SUPPLEMENT

Regular formula

Infant formula used for non breastfed children

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Modilac Pétunia 1 Modilac 1

Eligibility Criteria

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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

Maximum Eligible Age

8 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No