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

June 12, 2009 updated by: Sodilac

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Nantes, France, 44093
        • CHU de Nantes
      • Paris, France, 75651
        • Hopital de la Pitie Salpetriere
      • Paris, France, 75014
        • Hôpital Saint Vincent de Paul (AP-HP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modilac Pétunia 1
Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
Dietary supplement: Pétunia 1
Infant formula used for non breastfed children
Other Names:
  • Modilac Pétunia 1
Active Comparator: Modilac 1
Regular milk
Dietary supplement: Regular formula
Infant formula used for non breastfed children
Other Names:
  • Modilac 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth Parameters
Time Frame: 1, 3 and 6 months
1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitization or allergy
Time Frame: 1, 3 and 6 months
1, 3 and 6 months
Atopic diseases (eczema atopic, asthma, allergic rhinitis)
Time Frame: 1, 3 and 6 months
1, 3 and 6 months
Describe the intestinal flora according to the nutrition group
Time Frame: 1 and 6 months
1 and 6 months
Clinical Tolerance
Time Frame: 1 and 6 months
1 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sodilac

Investigators

  • Principal Investigator: Jean Christophe Rozé, PhD, CHU de Nantes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (Estimate)

June 15, 2009

Study Record Updates

Last Update Posted (Estimate)

June 15, 2009

Last Update Submitted That Met QC Criteria

June 12, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PET-CL3-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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