The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Completed · Not applicable

Conditions studied: Growth of Term Infants

In brief

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.

Key facts

Study ID

NCT01897922

Run by

Mead Johnson Nutrition

People needed

348

Starts

2013-07-01

Expected to finish

2014-04-01

Last updated by the study team

2015-09-25

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• History of underlying metabolic or chronic disease or immunocompromised
• Feeding difficulties or formula intolerance

Where it is running

• Birmingham Pediatric Associates — Birmingham, Alabama, United States
• Greenvale Pediatrics Hoover — Birmingham, Alabama, United States
• Southeastern Pediatric Associates — Dothan, Alabama, United States
• Pediatrics East - Alabama Clinical Therapeutics — Pinson, Alabama, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Arkkansas Pediatric Clinic — Little Rock, Arkansas, United States
• Norwich Pediatric Group, P.C. — Norwich, Connecticut, United States
• Children's Research, LLC — Altamonte Springs, Florida, United States
• Children's Medical Associations — Plantation, Florida, United States
• Deaconess Clinical Research — Evansville, Indiana, United States
• Owensboro Pediatrics — Owensboro, Kentucky, United States
• Woburn Pediatic Associates — Woburn, Massachusetts, United States
• Cary Pediatric Center, P.A. — Cary, North Carolina, United States
• Capital Pediatrics & Adolescent Center — Raleigh, North Carolina, United States
• Pediatric Associates of Mt. Carmel, Inc — Cincinnati, Ohio, United States
• Pediatric Associates of Fairfield, Inc. — Fairfield, Ohio, United States
• Parma Pediatrics, Inc — Parma, Ohio, United States
• UHMP Comprehensive Pediatrics — Westlake, Ohio, United States
• The Jackson Clinic - North Jackson — Jackson, Tennessee, United States
• Holston Medical Group — Kingsport, Tennessee, United States
• Austin Diagnostic Clinic — Austin, Texas, United States
• DCOL Center for Clinical Research — Longview, Texas, United States

Full record on ClinicalTrials.gov

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