Tolerance of Healthy Term Infants Fed Infant Formulas

NCT ID: NCT00705562

Last Updated: 2009-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-12-31

Brief Summary

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The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.

Detailed Description

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Conditions

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Infant, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Experimental milk protein based infant formula with varying carbohydrate and protein source

Group Type EXPERIMENTAL

milk protein formulas, varying carbohydrate/protein sources

Intervention Type OTHER

ad lib for 0-8 days of age until 28 days of age

2

Experimental milk protein based infant formula with varying carbohydrate and protein source

Group Type EXPERIMENTAL

milk protein formulas, varying carbohydrate/protein sources

Intervention Type OTHER

ad lib for 0-8 days of age until 28 days of age

3

Experimental milk protein based infant formula with varying carbohydrate and protein source

Group Type EXPERIMENTAL

milk protein formulas, varying carbohydrate/protein sources

Intervention Type OTHER

ad lib for 0-8 days of age until 28 days of age

4

Experimental milk protein based infant formula with varying carbohydrate and protein source

Group Type EXPERIMENTAL

milk protein formulas, varying carbohydrate/protein sources

Intervention Type OTHER

ad lib for 0-8 days of age until 28 days of age

5

Experimental milk protein based infant formula with varying carbohydrate and protein source

Group Type EXPERIMENTAL

milk protein formulas, varying carbohydrate/protein sources

Intervention Type OTHER

ad lib for 0-8 days of age until 28 days of age

Interventions

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milk protein formulas, varying carbohydrate/protein sources

ad lib for 0-8 days of age until 28 days of age

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

8 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Nutrition

Principal Investigators

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Steven Davis, PhD

Role: STUDY_DIRECTOR

Abbott Nutrition

Locations

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Global Clinical Investigation

Aventura, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

University of Iowa

Coralville, Iowa, United States

Site Status

Medical Associates Clinic

Dubuque, Iowa, United States

Site Status

Kentucky Pediatric Research

Bardstown, Kentucky, United States

Site Status

PediaResearch, Inc

Owensboro, Kentucky, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Midwest Children's Health Research Institute, LLC

Lincoln, Nebraska, United States

Site Status

The Center for Human Nutrition

Omaha, Nebraska, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Pediatric Associates of Fairfield

Fairfield, Ohio, United States

Site Status

Ohio Pediatric Research Association

Huber Heights, Ohio, United States

Site Status

Institute of Clinical Research

Mayfield Heights, Ohio, United States

Site Status

Primary Physicians Research, Inc

Pittsburgh, Pennsylvania, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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AK62

Identifier Type: -

Identifier Source: org_study_id

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