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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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 :
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.
Primary purpose
Allocation
Interventional model
Masking
114 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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