Clinical trial NCT01909661: Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cow Milk Protein Sensitivity
Tolerance
Growth Failure
Keywords: allergy
Cow's milk protein
Tolerance
Efficacy
Infants' growth
Lead sponsor: Lactalis
Sponsor class: INDUSTRY
Collaborators: name: Biosearch S.A.
First posted: 2013-07-26
Enrollment: 114
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.
timeFrame: 24h
Secondary outcomes:
measure: Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.
timeFrame: 3 months
Other outcomes:
measure: Volume of infant formula consumed by the infants
timeFrame: 3 months
Locations:
city: Granada
country: Spain
facility: Biosearch S.A.
Study officials:
References: