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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
extensively hydrolyzed formula with HMOs
extensively hydrolyzed formula without HMOs
Hoag Medical Group
Huntington Beach, California, United States
Stanford University
Mountain View, California, United States
Clinical Research Institute
Plymouth, Minnesota, United States
allergic reaction post DBPCFC
subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators
Time frame: 2 hours
stool characteristics
collected on daily diaries
Time frame: 1 week
formula intake
amount of formula ingested daily
Time frame: 1 week
adverse events
adverse events as reported by caregivers
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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