Tolerability and Safety of An Infant Formula

NCT ID: NCT00938483

Last Updated: 2009-07-15

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

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

Brief Summary

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The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.

Detailed Description

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Conditions

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Milk Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Extensively hydrolyzed infant formula

New extensively hydrolyzed formula, NPS-202

Group Type EXPERIMENTAL

Nutramigen Lipil (Infant formula)

Intervention Type OTHER

Infant formula - Extensively hydrolyzed Nutramigen Lipil

Currently marketed extensively hydrolyzed formula (Nutramigen Lipil)

Group Type ACTIVE_COMPARATOR

Nutramigen Lipil (Infant formula)

Intervention Type OTHER

Interventions

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Nutramigen Lipil (Infant formula)

Intervention Type OTHER

Other Intervention Names

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Extensively hydrolyed infant formula (Nutramigen Lipil)

Eligibility Criteria

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Inclusion Criteria

* clinically diagnosed CMA
* \</= 12 weeks at time of study entry
* full-term infant
* must be willing to use provided formula as sole source of nutrition
* other than CMA, infant must be otherwise healthy

Exclusion Criteria

* underlying or confounding gastrointestinal abnormalities
* infants born from an addictive situation, HIV positive
* if parent/guardian is considered likely to be non-compliant with the protocol requirements
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Perrigo Nutritionals

INDUSTRY

Sponsor Role lead

Responsible Party

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PBM Products, LLC

Principal Investigators

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Cynthia M Barber, PhD

Role: STUDY_DIRECTOR

Perrigo Nutritionals

Other Identifiers

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CTP-0010

Identifier Type: -

Identifier Source: org_study_id

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