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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01897922
First received: July 3, 2013
Last updated: July 18, 2014
Last verified: July 2014
  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-Blind
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Recall of infant formula intake at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Body length measured at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Recall of stool consistency measured at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Medically-confirmed adverse events collected throughout the study period [ Time Frame: 3.5 months ] [ Designated as safety issue: Yes ]
  • Parental Study Product Assessment Questionnaire completed at Study Visit 2 [ Time Frame: once ] [ Designated as safety issue: No ]
  • Head circumference measured at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]
  • Recall of gastrointestinal tolerance measured at each study visit [ Time Frame: 3.5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 314
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

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01897922     History of Changes
Other Study ID Numbers: 3385-2
Study First Received: July 3, 2013
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 27, 2014