Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants

June 12, 2012 updated by: Abbott Nutrition
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 2
  • Phase 3

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital Research Institute
    • Florida
      • Plantation, Florida, United States, 33324
        • All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
      • St. Petersburg, Florida, United States, 33710
        • SCORE Physician Alliance, LLC
      • Tampa, Florida, United States, 33606
        • University of South Florida Health Pediatrics
    • Georgia
      • Dalton, Georgia, United States, 30721
        • North Georgia Clinical Research
    • Iowa
      • Dubuque, Iowa, United States, 52002
        • Medical Associates Clinic
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Kentucky Pediatric Research
      • Owensboro, Kentucky, United States, 42301
        • PediaResearch, LLC
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institute, LLC
      • Omaha, Nebraska, United States, 68105
        • Center for Human Nutrition
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Pediatric Associates of Mount Carmel, Inc
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Dayton, Ohio, United States, 45406
        • Dayton Clinical Research
      • Huber Heights, Ohio, United States, 45424
        • Ohio Pediatric Research Association
      • Mayfield Heights, Ohio, United States, 44124
        • Institute of Clinical Research, LLC
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15241
        • Primary Physician's Research, Inc
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University, Department of Pediatrics

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
  • Infant's birth weight was > 2490 g (~5 lb 8 oz).
  • Infant is between 0 and 8 days of age at enrollment.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant for the duration of the study.
  • Infants using medications or home remedies, herbal preparations or rehydration/intravenous (IV) fluids that might affect GI tolerance may not be enrolled.

Exclusion Criteria:

  • An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant has been treated with antibiotics.
  • Infant has received probiotics.

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: Soy formula
experimental soy formula #1
Other: soy protein formula
ad lib for 0-35 days of age
Other Names:
  • experimental soy formula
Active Comparator: 2: Soy Formula
Commercially available soy formula
Other: Commercially available soy formula
ad lib for 0-35 days of age
Experimental: 3: Soy formula
experimental soy formula #2
Other: Soy formula experimental #2
ad lib for 0-35 days of age
Other Names:
  • Experimental soy formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Gastrointestinal tolerance from Study Visit 1 to Study Visit 3 at 35 days of age.
Time Frame: 35 days
35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional gastrointestinal measures of tolerance from Study Visit 1 to Study Visit 3 at 35 days of age
Time Frame: 35 days
35 days

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: John Lasekan, 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

December 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • AK54

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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