Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Société des Produits Nestlé (SPN)8 sites in 1 country83 target enrollmentApril 2015

ConditionsCow's Milk Allergy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cow's Milk Allergy
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 83
Locations: 8
Primary Endpoint: allergic reaction
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

June 2017

Last Updated

8 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 \<4 years of age at enrollment
•Documented CMA within 6 months prior to enrollment
•Otherwise healthy
•Having obtained his/her legal representative's informed consent

Exclusion Criteria

•Children consuming mother's milk at the time of inclusion and during the trial
•Any chromosomal or major congenital anomalies
•Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
•Immunodeficiency
•Receiving free amino acid formula
•Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
•Currently participating in another clinical trial.