Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula

Société des Produits Nestlé (SPN)9 sites in 1 country37 target enrollmentApril 2012

ConditionsFood Hypersensitivity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Food Hypersensitivity
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 37
Locations: 9
Primary Endpoint: occurrence of allergic reactions
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Born at term (\>36 weeks gestation)
•2 months to ≤12 years of age at enrollment
•Documented CMA within 6 months prior to enrollment
•Otherwise healthy
•Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
•Expected daily intake of at least 8 oz (240ml) of the study formula during the open challenge phase
•Having obtained his/her legal representative's informed consent
•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