Assessing Early Behavioral Indicators of Formula Tolerance

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-08-31

Brief Summary

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The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

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Detailed Description

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Conditions

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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

Marketed partially hydrolyzed cow's milk protein infant formula

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Marketed partially hydrolyzed cow's milk protein infant formula

Investigational

Partially hydrolyzed cow's milk infant formula with a probiotic

Group Type EXPERIMENTAL

Investigational

Intervention Type OTHER

Partially hydrolyzed cow's milk protein infant formula with a probiotic

Interventions

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Control

Marketed partially hydrolyzed cow's milk protein infant formula

Intervention Type OTHER

Investigational

Partially hydrolyzed cow's milk protein infant formula with a probiotic

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Singleton at birth
* Term infant with birth weight of 2500 g or more
* Crying or fussing for 3 or more hours per day
* Consuming mostly infant formula
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria

* Current use of extensively hydrolyzed or amino acid infant formula
* Planned use of probiotics during the study
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Enrollment in another interventional clinical research study

Minimum Eligible Age

14 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes