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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897922
First Posted: July 12, 2013
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mead Johnson Nutrition
  Purpose
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.

Condition Intervention
Growth of Term Infants Other: An investigational infant formula containing a probiotic source Other: Control: Marketed routine infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Body weight measured at each study visit [ Time Frame: 3.5 months ]

Secondary Outcome Measures:
  • Recall of infant formula intake at each study visit [ Time Frame: 3.5 months ]
  • Body length measured at each study visit [ Time Frame: 3.5 months ]
  • Recall of stool consistency measured at each study visit [ Time Frame: 3.5 months ]
  • Medically-confirmed adverse events collected throughout the study period [ Time Frame: 3.5 months ]
  • Parental Study Product Assessment Questionnaire completed at Study Visit 2 [ Time Frame: once ]
  • Head circumference measured at each study visit [ Time Frame: 3.5 months ]
  • Recall of gastrointestinal tolerance measured at each study visit [ Time Frame: 3.5 months ]

Enrollment: 348
Study Start Date: July 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marketed routine infant formula Other: Control: Marketed routine infant formula
Experimental: Infant formula containing a probiotic source Other: An investigational infant formula containing a probiotic source

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897922


Locations
United States, Alabama
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35205
Greenvale Pediatrics Hoover
Birmingham, Alabama, United States, 35244
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, United States, 35126
United States, Arkansas
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States, 72401
Arkkansas Pediatric Clinic
Little Rock, Arkansas, United States, 72205
United States, Connecticut
Norwich Pediatric Group, P.C.
Norwich, Connecticut, United States, 06360
United States, Florida
Children's Research, LLC
Altamonte Springs, Florida, United States, 32701
Children's Medical Associations
Plantation, Florida, United States, 33324
United States, Indiana
Deaconess Clinical Research
Evansville, Indiana, United States, 47713
United States, Kentucky
Owensboro Pediatrics
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Woburn Pediatic Associates
Woburn, Massachusetts, United States, 01801
United States, North Carolina
Cary Pediatric Center, P.A.
Cary, North Carolina, United States, 27518
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, United States, 27609
United States, Ohio
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, United States, 45245
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, United States, 45014
Parma Pediatrics, Inc
Parma, Ohio, United States, 44129
UHMP Comprehensive Pediatrics
Westlake, Ohio, United States, 44145
United States, Tennessee
The Jackson Clinic - North Jackson
Jackson, Tennessee, United States, 38305
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Austin Diagnostic Clinic
Austin, Texas, United States, 78749
DCOL Center for Clinical Research
Longview, Texas, United States, 75605
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Carol Lynn Berseth, M.D. Mead Johnson Nutrition
  More Information

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01897922     History of Changes
Other Study ID Numbers: 3385-2
First Submitted: July 3, 2013
First Posted: July 12, 2013
Last Update Posted: September 25, 2015
Last Verified: September 2015