The Effect of Infant Feeding on Stool Characteristics

September 4, 2008 updated by: Mead Johnson Nutrition
Infants will be fed infant formula and stool characteristics assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

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

    • Arkansas
      • Benton, Arkansas, United States, 72019
        • Central Arkansas Pediatric Clinic
      • Conway, Arkansas, United States, 22401
        • Arkansas Pediatrics of Conway
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Altamonte Pediatric Associates
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Advocate Center for Pediatric Research
    • Indiana
      • Fishers, Indiana, United States, 46038
        • Internal Medicine and Pediatrics
      • Indianapolis, Indiana, United States, 46229
        • East Washington Pediatrics
    • Iowa
      • Coralville, Iowa, United States, 52241
        • Children's Hospital of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical University
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • PTCU/Children and Youth Project
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • ACC Pediatric Research
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • ProMed HealthCare
      • Portage, Michigan, United States, 49024
        • ProMed Pediatrics
      • Richland, Michigan, United States, 49083
        • ProMed Physicians-Pediatrics
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • The Center for Human Nutrition
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop Pediatric Associates
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Cary Pediatric Center, P.A.
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Pediatric Associates of Mt. Carmel, Inc.
      • Fairfield, Ohio, United States, 45014
        • Pediatric Associates of Fairfield, Inc.
      • Mason, Ohio, United States, 45040
        • Northeast Cincinnati Pediatric Assoc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Red Lion Pediatrics
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Alpha Clinical Research
    • Texas
      • Austin, Texas, United States, 78745
        • Austin Diagnostic Clinic

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

3 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, term infants
  • 21-30 days of age

Exclusion Criteria:

  • Infants with feeding difficulties
  • Use of antibiotics or steroids

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
cow-milk based infant formula
ad lib feeding
Experimental: 2
cow milk based infant formula with prebiotics
ad lib feeding
Other: 3
human milk reference group
ad lib feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fecal bacteria analysis
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Intake, tolerance, stool characteristics, anthropometrics
Time Frame: 60 days
60 days

Collaborators and Investigators

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

Investigators

  • Study Director: Deolinda Scalabrin, MD, Mead Johnson Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

August 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 18, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

September 5, 2008

Last Update Submitted That Met QC Criteria

September 4, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 33715

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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