Soy Formula Feedings in Healthy, Term Infants

NCT ID: NCT02456831

Last Updated: 2015-05-29

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

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-12-31

Study Completion Date

1994-06-30

Brief Summary

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This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

Detailed Description

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Conditions

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Gastrointestinal Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Infant Formula

Ready-to-Feed (RTF) Soy Infant Formula

Group Type ACTIVE_COMPARATOR

Active Comparator: Control Infant Formula

Intervention Type OTHER

Ready-to-Feed (RTF) Soy Infant Formula

Experimental Infant Formula 1

Experimental Ready-to-Feed Soy Formula

Group Type EXPERIMENTAL

Experimental Infant Formula 1

Intervention Type OTHER

method A phytate reduction and 5% protein hydrolysis

Experimental Infant Formula 2

Experimental Ready-to-Feed Soy Formula

Group Type EXPERIMENTAL

Experimental Infant Formula 2

Intervention Type OTHER

method A phytate reduction and 10% protein hydrolysis

Experimental Infant Formula 3

Experimental Ready-to-Feed Soy Formula

Group Type EXPERIMENTAL

Experimental Infant Formula 3

Intervention Type OTHER

method B phytate reduction and 5% protein hydrolysis

Interventions

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Experimental Infant Formula 1

method A phytate reduction and 5% protein hydrolysis

Intervention Type OTHER

Experimental Infant Formula 2

method A phytate reduction and 10% protein hydrolysis

Intervention Type OTHER

Experimental Infant Formula 3

method B phytate reduction and 5% protein hydrolysis

Intervention Type OTHER

Active Comparator: Control Infant Formula

Ready-to-Feed (RTF) Soy Infant Formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
* Health infants reported to be tolerating a milk-based formula (Cohorts).
* Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

9 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Lasekan, MBA, PhD, CCRP

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Dreyer Clinic

Aurora, Illinois, United States

Site Status

T&W Research

Owensboro, Kentucky, United States

Site Status

Park Nicollet Medical Foundation

Minneapolis, Minnesota, United States

Site Status

Clinical Studies, Inc

Canton, Ohio, United States

Site Status

Research Memphis

Memphis, Tennessee, United States

Site Status

Child Care Associates

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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AE58

Identifier Type: -

Identifier Source: org_study_id