The purpose of the study is to assess if infants who have excessive crying and fussing have less of these symptoms when fed a formula containing a probiotic compared to those fed a standard infant formula.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
65
formula supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days duration
supplied as a powder to be constituted as commercially available formula ad libitum daily 28 days
Children's Investigational Research Program, LLC
Bentonville, Arkansas, United States
University of California, San Francisco
San Francisco, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
daily total crying time
Time frame: 28 days
Formula intake
Time frame: 4 days
Tolerance evaluated by stool, vomiting, spitting and flatulence frequencies
Time frame: 4 days
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