Tolerance of Healthy, Term Infants to Infant Formulas

July 3, 2008 updated by: Abbott Nutrition
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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
      • North Little Rock, Arkansas, United States, 72117
        • The Pediatric Clinic
    • Florida
      • Tampa, Florida, United States, 33606
        • USF
    • Georgia
      • Dalton, Georgia, United States, 30721
        • North Georgia Clinical Research, White's Pediatrics
    • Iowa
      • Dubuque, Iowa, United States, 52001
        • Medical Associates Clinic
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute, LLC
    • New York
      • Poughkeepsie, New York, United States, 12603
        • The Childrens Medical Group LLC
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Levine Childrens Hospital
    • Ohio
      • Huber Heights, Ohio, United States, 45424
        • Ohio Pediatrics, Inc.
      • Mayfield Heights, Ohio, United States, 44124
        • Institute of Clinical Research
    • Texas
      • Temple, Texas, United States, 78508
        • Scott & White Memorial Hospital

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:

  • judged to be in good health.
  • singleton from a full term birth with a gestational age of 37-42 weeks
  • birth weight was > 2490 g (~5 lbs 8 oz)
  • between 0 and 8 days of age at enrollment.
  • Infant's parent(s) or a LAR has voluntarily signed and dated an ICF, approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

  • An adverse maternal, fetal or infant medical history thought by the investigator to have potential for effects on tolerance, growth, and/or development, including, but not limited to suspected maternal substance abuse.
  • Infant has been treated with antibiotics.

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: Milk based formula A
Experimental milk based infant formula
Other: Milk based formula A
feed as per HCP directions
Other Names:
  • AN0710A
Active Comparator: Standard formula
standard milk based infant formula
Other: #2 Standard formula
Feed as per HCP directions
Other Names:
  • AN0710B
Other: Reference
Human milk
Other: #3 Human Milk
Feed as per HCP directions
Other Names:
  • Human Milk
Experimental: Milk based formula C
Experimental milk based infant formula
Other: Milk based formula C
Feed as per HCP direction
Other Names:
  • AN0710C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean rank stool consistency (MRSC)
Time Frame: Study Day 1 to Visit 3
Study Day 1 to Visit 3

Secondary Outcome Measures

Outcome Measure
Time Frame
MRSC, percent watery stools, average number of stools per day, percent of feedings with spit-up and/or vomiting
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Timberly A. Williams, M.S., Abbott Nutrition, Abbott Laboratories

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.

General Publications

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

September 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

July 4, 2008

Last Update Submitted That Met QC Criteria

July 3, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AK53

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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