Clinical Trial Details

Overview

Research Study Summary

Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Purpose

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.

To Learn more

CW ID: 209891
Date Last Changed: August 18, 2015

Clinical Trial Snapshot

Gender
Both Male and Female
Age
2 to 4 Years
Overall Status
Recruiting
Lead Sponsor
Nestlé
Facility Type
N/A

Eligibility

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.

More Info

Protocol Number: 14.24.CLI

Contact

Jessica Trotter
University of South Florida- All Children's Hospital
501 6th Ave South
St. Petersburg, FL 33701
Phone: 727-553-1259

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