Feeding Tolerance Evaluation

NCT ID: NCT02405572

Last Updated: 2016-05-12

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Brief Summary

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Crossover study of 2 infant formulas

Detailed Description

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Exclusively formula-fed infants will participate in two 2-week feeding periods of 2 infant formulas. Daily tolerance records will be kept by caregivers.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Formula 1

infant formula

Group Type ACTIVE_COMPARATOR

infant formula

Intervention Type OTHER

infant formulas

Formula 2

infant formula

Group Type ACTIVE_COMPARATOR

infant formula

Intervention Type OTHER

infant formulas

Interventions

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infant formula

infant formulas

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy newborn infant
* Full-term (\> 37 weeks gestation)
* 0-2 months (birth-56 days) of age on enrollment
* Infant exclusively formula-fed for at least 2 days prior to enrollment
* Having obtained his/her legal representative's informed consent

Exclusion Criteria

* Known or suspected cow-milk allergy
* Congenital illness or malformation
* Significant prenatal and/or postnatal disease
* Currently participating in another clinical study
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rich Litov, PhD

Role: PRINCIPAL_INVESTIGATOR

Pedia Research

Locations

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Pedia Research

Owensboro, Kentucky, United States

Site Status

Tanner Clinic

Layton, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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14.32.US.INF

Identifier Type: -

Identifier Source: org_study_id

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