Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Sponsored by Société des Produits Nestlé (SPN)

About this trial

Last updated 7 years ago

Study ID

16.16.CLI

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

2 to 4 Years

All Sexes

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

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

* Anaphylaxis to any food

* 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