Tolerancia a 2 fórmulas de Leche Infantil Altamente Hidrolizadas en Base a proteínas de Arroz y a caseína en niños Con Alergia a Las proteínas de Leche de Vaca

Lactalis1 site in 1 country114 target enrollmentMarch 2013

ConditionsCow Milk Protein Sensitivity Tolerance Growth Failure

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cow Milk Protein Sensitivity
Sponsor: Lactalis
Enrollment: 114
Locations: 1
Primary Endpoint: Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lactalis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Full term healthy newborns (37-42 Weeks gestation)
•Weight at birth ≥ 2500 g
•Aged between birth to 9 months
•Symptoms of allergy (Skin or digetive)
•Suspicion of cow milk protein allergy
•Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
•Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study

Exclusion Criteria

•Children who have returned to breastfeeding
•Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
•In the past 15 days, treatment or medication likely to :
•induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
•mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, ...)
•Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
•Children who show signs of malnutrition, or prolonged diarrhea
•Children whose parents show no willingness to comply with study requirements
•Consumption of soya protein based, hydrolyzed protein or elemental (amino acid) formula for more than 21 days before inclusion, unless the skin prick test to cow's milk protein is positive, and the IgE level indicates the existence of IgE mediated allergy to cow's milk protein.