Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
259
Experimental formula
Standard Infant formula
The Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Asian Hospital and Medical Center
City of Muntinlupa, Philippines
Chang Gung Memorial Hospital - Linkou
Hsiang, Taoyan Hsien, Taiwan
Mackay Memorial Hospital - Tamsui
New Taipei City, Taiwan
Changes from baseline to 14 days in fuss-cry behavior
fuss-cry behavior per 24 hours
Time frame: from baseline to 14 days
Change from baseline to 14 days in GI symptoms
Time frame: from baseline to 14 days
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Mackay Memorial Hospital - Taipei
Taipei, Taiwan
King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University
Pratumwan, Bangkok, Thailand