Prospective, double-blind, randomized study of 2 infant formulas.
Exclusively formula-fed infants will participate in a 6-week feeding period of an infant formula. Tolerance records will be kept for 2 days at the end of the 6-week period by caregivers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Routine infant formula with probiotic
Routine infant formula with probiotic and prebiotic
Avanza Medical Research Center
Pensacola, Florida, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States
PediaResearch
Owensboro, Kentucky, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
Infant GI Symptom Burden
Study personnel will administer questionnaire
Time frame: 6 weeks
Stool pattern
Caregivers will document on diary records
Time frame: 6 weeks
Spit-up and/or vomiting pattern
Caregivers will document on diary records
Time frame: 6 weeks
Crying and fussing duration
Caregivers will document on diary records
Time frame: 6 weeks
Formula intake
Caregivers will document on diary records
Time frame: 6 weeks
Formula satisfaction questionnaire
Study personnel will administer questionnaire
Time frame: 6 weeks
Weight (measured in grams)
Study personnel will measure
Time frame: Enrollment and 6 weeks
Length (measured in centimeters)
Study personnel will measure
Time frame: Enrollment and 6 weeks
Adverse events
Assessed throughout study
Time frame: 2 weeks and 6 weeks
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Coastal Pediatric Associates
Charleston, South Carolina, United States
Midsouth Center for Clinical Research, LLC
Memphis, Tennessee, United States
Southwest Children's Research Associates
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States