The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
- Conditions
- Growth of Term Infants
- Interventions
- Other: An investigational infant formula containing a probiotic source
- Registration Number
- NCT01897922
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 348
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or formula intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infant formula containing a probiotic source An investigational infant formula containing a probiotic source -
- Primary Outcome Measures
Name Time Method Body weight measured at each study visit 3.5 months
- Secondary Outcome Measures
Name Time Method Medically-confirmed adverse events collected throughout the study period 3.5 months Recall of infant formula intake at each study visit 3.5 months Recall of stool consistency measured at each study visit 3.5 months Parental Study Product Assessment Questionnaire completed at Study Visit 2 once Head circumference measured at each study visit 3.5 months Recall of gastrointestinal tolerance measured at each study visit 3.5 months Body length measured at each study visit 3.5 months
Trial Locations
- Locations (22)
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
Pediatrics East - Alabama Clinical Therapeutics
🇺🇸Pinson, Alabama, United States
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Greenvale Pediatrics Hoover
🇺🇸Birmingham, Alabama, United States
Children's Research, LLC
🇺🇸Altamonte Springs, Florida, United States
Arkkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Norwich Pediatric Group, P.C.
🇺🇸Norwich, Connecticut, United States
Owensboro Pediatrics
🇺🇸Owensboro, Kentucky, United States
Children's Medical Associations
🇺🇸Plantation, Florida, United States
Deaconess Clinical Research
🇺🇸Evansville, Indiana, United States
Cary Pediatric Center, P.A.
🇺🇸Cary, North Carolina, United States
Woburn Pediatic Associates
🇺🇸Woburn, Massachusetts, United States
Capital Pediatrics & Adolescent Center
🇺🇸Raleigh, North Carolina, United States
Pediatric Associates of Mt. Carmel, Inc
🇺🇸Cincinnati, Ohio, United States
Parma Pediatrics, Inc
🇺🇸Parma, Ohio, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
Austin Diagnostic Clinic
🇺🇸Austin, Texas, United States
UHMP Comprehensive Pediatrics
🇺🇸Westlake, Ohio, United States
The Jackson Clinic - North Jackson
🇺🇸Jackson, Tennessee, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States