Clinical trial NCT01897922: The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
Official title: The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth of Term Infants
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 348
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Body weight measured at each study visit
timeFrame: 3.5 months
Secondary outcomes:
measure: Recall of infant formula intake at each study visit
timeFrame: 3.5 months
measure: Body length measured at each study visit
timeFrame: 3.5 months
measure: Recall of stool consistency measured at each study visit
timeFrame: 3.5 months
measure: Medically-confirmed adverse events collected throughout the study period
timeFrame: 3.5 months
measure: Parental Study Product Assessment Questionnaire completed at Study Visit 2
timeFrame: once
measure: Head circumference measured at each study visit
timeFrame: 3.5 months
measure: Recall of gastrointestinal tolerance measured at each study visit
timeFrame: 3.5 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Birmingham
country: United States
facility: Greenvale Pediatrics Hoover
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Pinson
country: United States
facility: Pediatrics East - Alabama Clinical Therapeutics
state: Alabama
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: Arkkansas Pediatric Clinic
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, P.C.
state: Connecticut
city: Altamonte Springs
country: United States
facility: Children's Research, LLC
state: Florida
city: Plantation
country: United States
facility: Children's Medical Associations
state: Florida
city: Evansville
country: United States
facility: Deaconess Clinical Research
state: Indiana
city: Owensboro
country: United States
facility: Owensboro Pediatrics
state: Kentucky
city: Woburn
country: United States
facility: Woburn Pediatic Associates
state: Massachusetts
city: Cary
country: United States
facility: Cary Pediatric Center, P.A.
state: North Carolina
city: Raleigh
country: United States
facility: Capital Pediatrics & Adolescent Center
state: North Carolina
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: Parma
country: United States
facility: Parma Pediatrics, Inc
state: Ohio
city: Westlake
country: United States
facility: UHMP Comprehensive Pediatrics
state: Ohio
city: Jackson
country: United States
facility: The Jackson Clinic - North Jackson
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Austin Diagnostic Clinic
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, M.D.
role: STUDY_DIRECTOR
References: