Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Status:	Completed
Conditions:	Allergy
Therapuetic Areas:	Otolaryngology
Healthy:	No
Age Range:	Any - 4
Updated:	8/2/2017
Start Date:	April 2015
End Date:	June 2017

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.

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.

We found this trial at

sites

Allergy and Sinus Relief Center/Great Lakes Medical research

Chardon, Ohio 44024

Principal Investigator: Lavi, MD

from

Chardon, OH