Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula

Société des Produits Nestlé (SPN)14 sites in 1 countryFebruary 2011

Overview

The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

August 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

•Born at term (\>36 weeks gestation)
•Two (2) months to ≤ 12 years of age at enrollment
•Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
•Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and \[detectable serum milk-specific IgE (\>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm\]), OR
•Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
•Results of laboratory tests highly predictive of clinical reactivity to milk
•Serum milk IgE ≥15 \[kIU/L\]or ≥ 5 \[kIU/L if younger than 1 year OR,
•Skin prick tests mean wheal \>10 mm
•Otherwise healthy
•If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled

•Children consuming mother's milk at the time of inclusion and during the trial
•Any chromosomal or major congenital anomalies
•Any major gastrointestinal disease or abnormalities other than CMA
•Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
•Immunodeficiency
•Receiving free amino acid formula
•Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
•Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
•Unstable asthma
•Severe uncontrolled eczema