Clinical trial NCT00920166: Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
Official title: Growth and Tolerance in New Born Fed Formula Supplemented With Alpha-Lactalbumin and Containing a Symbiotic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth
Keywords: Infant formula
Alpha-lactalbumin
Symbiotic
Allergy
Gastrointestinal tolerance
Bacterial colonization
Faecal IgA analysis
Lead sponsor: Sodilac
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 97
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Growth Parameters
timeFrame: 1, 3 and 6 months
Secondary outcomes:
measure: Sensitization or allergy
timeFrame: 1, 3 and 6 months
measure: Atopic diseases (eczema atopic, asthma, allergic rhinitis)
timeFrame: 1, 3 and 6 months
measure: Describe the intestinal flora according to the nutrition group
timeFrame: 1 and 6 months
measure: Clinical Tolerance
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hôpital Saint Vincent de Paul (AP-HP)
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
Study officials:
affiliation: Nantes University Hospital
name: Jean Christophe Rozé, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roze 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 alpha-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.