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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

June 12, 2009
June 12, 2009
February 2007
March 2008   (final data collection date for primary outcome measure)
Growth Parameters [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Growth
  • Dietary Supplement: Pétunia 1
    Infant formula used for non breastfed children
    Other Name: Modilac Pétunia 1
  • Dietary Supplement: Regular formula
    Infant formula used for non breastfed children
    Other Name: Modilac 1
  • Experimental: Modilac Pétunia 1
    Formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic
    Intervention: Dietary Supplement: Pétunia 1
  • Active Comparator: Modilac 1
    Regular milk
    Intervention: Dietary Supplement: Regular formula
Rozé JC, Barbarot S, Butel MJ, Kapel N, Waligora-Dupriet AJ, De Montgolfier I, Leblanc M, Godon N, Soulaines P, Darmaun D, Rivero M, Dupont C. An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial. Br J Nutr. 2012 Jun;107(11):1616-22. doi: 10.1017/S000711451100479X. Epub 2011 Nov 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
up to 8 Days
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00920166
PET-CL3-001
No
Pr Jean Christophe Rozé (Principal investigator), CHU de Nantes
Sodilac
Not Provided
Principal Investigator: Jean Christophe Rozé, PhD CHU de Nantes
Sodilac
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP