Extensively Hydrolyzed Formula: Hypoallergenicity

Completed · Not applicable

Conditions studied: Food Hypersensitivity

In brief

The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.

Key facts

Study ID

NCT01278446

Run by

Société des Produits Nestlé (SPN)

Starts

2011-02-01

Expected to finish

2012-08-01

Last updated by the study team

2013-11-04

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Born at term (>36 weeks gestation)
• Two (2) months to ≤ 12 years of age at enrollment
• Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
• Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and [detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm]), OR
• Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
• Results of laboratory tests highly predictive of clinical reactivity to milk
• Serum milk IgE ≥15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year OR,
• Skin prick tests mean wheal >10 mm
• Otherwise healthy
• If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
• Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
• 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
• Any major gastrointestinal disease or abnormalities other than CMA
• Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
• Immunodeficiency
• Receiving free amino acid formula
• Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
• Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
• Unstable asthma
• Severe uncontrolled eczema
• Recent ( within the last 3 months) severe anaphylactic reaction to milk
• 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

• Little Rock Allergy & Asthma — Little Rock, Arkansas, United States
• Pediatric Care Medical Group, Inc — Huntington Beach, California, United States
• Allergy Medical Group of the North Area — Roseville, California, United States
• Brookstone Clinical Research Center — Columbus, Georgia, United States
• Aeroallergy Research Labs of Savannah — Savannah, Georgia, United States
• Idaho Allergy and Asthma Specialists — Eagle, Idaho, United States
• Deaconness Clinic — Evansville, Indiana, United States
• Anderson & Collins Clinical Research — Edison, New Jersey, United States
• Mount Sinai Faculty Practice Associates Pediatric Allergy — New York, New York, United States
• ENT & Allergy Associates — Newburgh, New York, United States
• Allergy Partners of Western North Carolina — Asheville, North Carolina, United States
• TTS Research — Boerne, Texas, United States
• Clinical Research Partners — Henrico, Virginia, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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