Tolerance of Healthy Term Infants Fed Infant Formulas

January 2, 2009 updated by: Abbott Nutrition
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 2

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

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • Global Clinical Investigation
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Iowa
      • Coralville, Iowa, United States, 52241
        • University of Iowa
      • Dubuque, Iowa, United States, 52002
        • Medical Associates Clinic
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric Research
      • Owensboro, Kentucky, United States, 42301
        • PediaResearch, Inc
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute, LLC
      • Omaha, Nebraska, United States, 68105
        • The Center for Human Nutrition
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Fairfield, Ohio, United States, 45014
        • Pediatric Associates of Fairfield
      • Huber Heights, Ohio, United States, 45424
        • Ohio Pediatric Research Association
      • Mayfield Heights, Ohio, United States, 44124
        • Institute of Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physicians Research, Inc
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

No older than 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, term infants; singleton birth; 37-42 weeks of age; >2490gms at birth; 0-8 days of age

Exclusion Criteria:

  • medications/foods/formulas affecting GI tolerance;adverse medical history with possible effect on tolerance or growth

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 2
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 3
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 4
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age
Experimental: 5
Experimental milk protein based infant formula with varying carbohydrate and protein source
Other: milk protein formulas, varying carbohydrate/protein sources
ad lib for 0-8 days of age until 28 days of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastrointestinal tolerance
Time Frame: 0-8 days of age until 28 days of age
0-8 days of age until 28 days of age

Secondary Outcome Measures

Outcome Measure
Time Frame
GI and intake parameters
Time Frame: 0-8 to 28 days of age
0-8 to 28 days of age

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Study Director: Steven Davis, PhD, Abbott 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

June 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

January 5, 2009

Last Update Submitted That Met QC Criteria

January 2, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK62

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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