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

September 24, 2015 updated by: Mead Johnson Nutrition
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Marketed routine infant formula
Experimental: Infant formula containing a probiotic source

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight measured at each study visit
Time Frame: 3.5 months
3.5 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Carol Lynn Berseth, M.D., Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 3385-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth of Term Infants

Clinical Trials on Control: Marketed routine infant formula

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