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COMPLETEDNANCT03236207

Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

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 ar...

Lead sponsor: Société des Produits Nestlé (SPN)•12 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Société des Produits Nestlé (SPN)

Age

0 - 4 years

Sex

ALL

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 30, 2019Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment67

Start dateJul 2017

Last updatedJan 30, 2019

Condition

Cow Milk Allergy

Locations shown

Hoag Medical Group

Huntington Beach, California

Stanford University

Mountain View, California

Clinical Research Institute

Plymouth, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2019Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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