- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897922
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
Status
Completed
Conditions
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
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Birmingham, Alabama, United States, 35244
- Greenvale Pediatrics Hoover
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Dothan, Alabama, United States, 36305
- Southeastern Pediatric Associates
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Pinson, Alabama, United States, 35126
- Pediatrics East - Alabama Clinical Therapeutics
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Arkansas
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Jonesboro, Arkansas, United States, 72401
- The Children's Clinic of Jonesboro, P.A.
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Little Rock, Arkansas, United States, 72205
- Arkkansas Pediatric Clinic
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-
Connecticut
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Norwich, Connecticut, United States, 06360
- Norwich Pediatric Group, P.C.
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-
Florida
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Altamonte Springs, Florida, United States, 32701
- Children's Research, LLC
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Plantation, Florida, United States, 33324
- Children's Medical Associations
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-
Indiana
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Evansville, Indiana, United States, 47713
- Deaconess Clinical Research
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Kentucky
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Owensboro, Kentucky, United States, 42303
- Owensboro Pediatrics
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Massachusetts
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Woburn, Massachusetts, United States, 01801
- Woburn Pediatic Associates
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North Carolina
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Cary, North Carolina, United States, 27518
- Cary Pediatric Center, P.A.
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Raleigh, North Carolina, United States, 27609
- Capital Pediatrics & Adolescent Center
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Ohio
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Cincinnati, Ohio, United States, 45245
- Pediatric Associates of Mt. Carmel, Inc
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Fairfield, Ohio, United States, 45014
- Pediatric Associates of Fairfield, Inc.
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Parma, Ohio, United States, 44129
- Parma Pediatrics, Inc
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Westlake, Ohio, United States, 44145
- UHMP Comprehensive Pediatrics
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Tennessee
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Jackson, Tennessee, United States, 38305
- The Jackson Clinic - North Jackson
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Kingsport, Tennessee, United States, 37660
- Holston Medical Group
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Texas
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Austin, Texas, United States, 78749
- Austin Diagnostic Clinic
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Longview, Texas, United States, 75605
- DCOL Center for Clinical Research
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-
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.
Sponsor
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.
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