This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
69
sole source nutrition
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Watching Over Mothers and Babies
Tucson, Arizona, United States
Fussiness
Parent Questionnaires
Time frame: Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)
Fussiness
Parent Questionnaires
Time frame: Baseline to SDAY 29
Hours of daily crying
Parent Questionnaires
Time frame: Baseline to SDAY 29
Gastrointestinal Tolerance
Parent Questionnaires
Time frame: Baseline to SDAY 29
Stool Pattern
Parent Questionnaire
Time frame: Baseline to SDAY 29
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Norwich Pediatric Group, PC
Norwich, Connecticut, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, United States
Score Physician Alliance, LLC
St. Petersburg, Florida, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States
Institute of Clinical Research, LLC
Cleveland, Ohio, United States
Aventiv Research
Grove City, Ohio, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
...and 3 more locations