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

This study has been completed.
Sponsor:
Information provided by:
Sodilac
ClinicalTrials.gov Identifier:
NCT00920166
First received: June 12, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention Phase
Growth
Dietary Supplement: Pétunia 1
Dietary Supplement: Regular formula
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic

Resource links provided by NLM:


Further study details as provided by Sodilac:

Primary Outcome Measures:
  • Growth Parameters [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sensitization or allergy [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • Atopic diseases (eczema atopic, asthma, allergic rhinitis) [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • Describe the intestinal flora according to the nutrition group [ Time Frame: 1 and 6 months ] [ Designated as safety issue: No ]
  • Clinical Tolerance [ Time Frame: 1 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: February 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920166

Locations
France
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
Sodilac
Investigators
Principal Investigator: Jean Christophe Rozé, PhD CHU de Nantes
  More Information

No publications provided by Sodilac

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Jean Christophe Rozé (Principal investigator), CHU de Nantes
ClinicalTrials.gov Identifier: NCT00920166     History of Changes
Other Study ID Numbers: PET-CL3-001
Study First Received: June 12, 2009
Last Updated: June 12, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sodilac:
Infant formula
Alpha-lactalbumin
Symbiotic
Allergy
Gastrointestinal tolerance
Bacterial colonization
Faecal IgA analysis

ClinicalTrials.gov processed this record on August 21, 2014