Growth
Conditions
Keywords
Infant formula, Alpha-lactalbumin, Symbiotic, Allergy, Gastrointestinal tolerance, Bacterial colonization, Faecal IgA analysis
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.
Interventions
DIETARY_SUPPLEMENTPétunia 1
Infant formula used for non breastfed children
DIETARY_SUPPLEMENTRegular formula
Infant formula used for non breastfed children
Sponsors
Sodilac
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Days
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth Parameters | 1, 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Sensitization or allergy | 1, 3 and 6 months |
| Atopic diseases (eczema atopic, asthma, allergic rhinitis) | 1, 3 and 6 months |
| Describe the intestinal flora according to the nutrition group | 1 and 6 months |
| Clinical Tolerance | 1 and 6 months |
Countries
France
Outcome results
None listed