Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula

Completed · Not applicable

Conditions studied: Cow's 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

NCT02450643

Run by

Société des Produits Nestlé (SPN)

People needed

83

Starts

2015-04-01

Expected to finish

2017-06-01

Last updated by the study team

2017-08-01

Who can join

Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not 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
• 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

• Atria Clinical Research — Little Rock, Arkansas, United States
• Allergy and Asthma Associates of Southern California — Mission Viejo, California, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• AeroAllergy — Savannah, Georgia, United States
• Mt. Sinai — New York, New York, United States
• ENT & Allergy Associates — Newburgh, New York, United States
• Allergy and Sinus Relief Center/Great Lakes Medical research — Chardon, Ohio, United States
• Allergy Asthma Research Institute — Waco, Texas, United States

Full record on ClinicalTrials.gov

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