Growth Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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