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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00920166
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : June 15, 2009
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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.

Condition or disease Intervention/treatment Phase
Growth Dietary Supplement: Pétunia 1 Dietary Supplement: Regular formula Phase 3

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  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
Study Start Date : February 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

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 Name: Modilac Pétunia 1

Active Comparator: Modilac 1
Regular milk
Dietary Supplement: Regular formula
Infant formula used for non breastfed children
Other Name: Modilac 1

Primary Outcome Measures :
  1. Growth Parameters [ Time Frame: 1, 3 and 6 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00920166

CHU d'Angers
Angers, France, 49933
CHU de Nantes
Nantes, France, 44093
Hôpital Saint Vincent de Paul (AP-HP)
Paris, France, 75014
Hôpital de la Pitié Salpétrière
Paris, France, 75651
Sponsors and Collaborators
Principal Investigator: Jean Christophe Rozé, PhD CHU de Nantes

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pr Jean Christophe Rozé (Principal investigator), CHU de Nantes Identifier: NCT00920166     History of Changes
Other Study ID Numbers: PET-CL3-001
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 2009

Keywords provided by Sodilac:
Infant formula
Gastrointestinal tolerance
Bacterial colonization
Faecal IgA analysis