Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas (JUNGLO)

Lactalis

Status and phase

Completed

Phase 2

Conditions

Cow Milk Protein Sensitivity

Growth Failure

Tolerance

Treatments

Other: Picot riz/Celia rice/Sanutri arroz

Other: Damira/Celia peptide hydrolyzed casein

Study type

Interventional

Funder types

Industry

Identifiers

NCT01909661

LRD - 2013 - JUNGLO

Details and patient eligibility

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

114 patients

Sex

All

Ages

Under 9 months old

Volunteers

No Healthy Volunteers

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.