Alternate Formula Feedings in Formula Intolerant Infants

NCT ID: NCT02456805

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

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-08-31

Study Completion Date

1997-06-30

Brief Summary

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This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.

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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Infant Formula 1

A standard commercial milk-based infant formula

Group Type ACTIVE_COMPARATOR

Infant Formula 1

Intervention Type OTHER

Feed ab libitum

Infant Formula 2

A standard commercial soy-based infant formula.

Group Type EXPERIMENTAL

Infant Formula 2

Intervention Type OTHER

Feed ab libitum

Interventions

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Infant Formula 1

Feed ab libitum

Intervention Type OTHER

Infant Formula 2

Feed ab libitum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
* Infants whose physicians had made a recommendation that the parents change the infant's feeding.
* Full term infants at birth with a gestational age of 37 to 42 weeks.
* Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion Criteria

* Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
* Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.
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, Ph.D, CCRP

Role: STUDY_CHAIR

Abbott Nutrition

Locations

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Arkansas Children's Hospital

Little Rock, Alaska, United States

Site Status

Aurora Pediatric Associates

Aurora, Colorado, United States

Site Status

Northlake Pediatric, Associates

Stone Mountain, Georgia, United States

Site Status

The Medical Associates Clinic

Dubuque, Iowa, United States

Site Status

Baystate Medical Center, Children's Hospital

Springfield, Massachusetts, United States

Site Status

Clinical Studies, Inc

Canton, Ohio, United States

Site Status

Richmond Pediatrics

Richmond, Virginia, United States

Site Status

Optimum Clinical Research

Oshawa, , Canada

Site Status

Countries

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United States Canada

Other Identifiers

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AH23

Identifier Type: -

Identifier Source: org_study_id