The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
37
Amino Acid baby formula
Hypoallergenic Baby formula
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, United States
Georgia Pollens Clinical Research Centers Inc.
Albany, Georgia, United States
occurrence of allergic reactions
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
Time frame: 14 days
Digestive Tolerance
gastrointestinal tolerance and formula intake recorded during the open challenge phase.
Time frame: one week
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Allergy & Asthma Physicians
Hinsdale, Illinois, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Mount Sinai Medical Center
New York, New York, United States
ENT & Allergy Associates
Newburgh, New York, United States
TTS Research
Boerne, Texas, United States
Clinical Research Partners
Richmond, Virginia, United States