Acceptance Of A Partially-Hydrolyzed Infant Formula

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-21

Study Completion Date

2018-12-31

Brief Summary

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This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

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Detailed Description

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Conditions

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Stool

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Routine cow's milk-based infant formula

Investigational

Group Type EXPERIMENTAL

Investigational

Intervention Type OTHER

Partially-hydrolyzed cow's milk protein infant formula

Interventions

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Control

Routine cow's milk-based infant formula

Intervention Type OTHER

Investigational

Partially-hydrolyzed cow's milk protein infant formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Singleton 28-300 days of age at randomization
* Gestational age less than or equal to 35 weeks
* Receiving minimum 18oz infant formula in the 24hrs prior to randomization
* History of hard stools or stooling difficulty
* Signed informed consent and protected health information

Exclusion Criteria

* Current diagnosis of cow's milk protein allergy or intolerance
* Use of extensively hydrolyzed or amino acid formula at randomization
* Any abdominal or gastrointestinal surgery prior to randomization
* History of underlying metabolic or chronic disease or congenital malformation
* Organic causes of constipation

Minimum Eligible Age

28 Days

Maximum Eligible Age

300 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes