Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Completed · Not applicable

Conditions studied: Cow Milk Allergy

In brief

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.

Key facts

Study ID

NCT03236207

Run by

Société des Produits Nestlé (SPN)

People needed

67

Starts

2017-07-06

Expected to finish

2018-11-06

Last updated by the study team

2019-01-30

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hoag Medical Group — Huntington Beach, California, United States
• Stanford University — Mountain View, California, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• Midwest Clinical Research — St Louis, Missouri, United States
• Breathe America — Albuquerque, New Mexico, United States
• Northwell Health System — Great Neck, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Allergy, Asthma and Clinical Research Center — Oklahoma City, Oklahoma, United States
• Carolina ENT — Orangeburg, South Carolina, United States
• Memphis & Shelby County Pediatrics — Memphis, Tennessee, United States
• Houston Clinical Research Associates — Houston, Texas, United States
• Allergy Asthma Research Institute — Waco, Texas, United States

Full record on ClinicalTrials.gov

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