Exploratory/Proof of Principle Microbiota Study

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-07-31

Brief Summary

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This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

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Detailed Description

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This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Conditions

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Fecal Microbiota

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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Amino acid based infant formula

Group Type ACTIVE_COMPARATOR

Amino acid based infant formula

Intervention Type OTHER

Extensively hydrolyzed casein infant formula

Group Type EXPERIMENTAL

Extensively hydrolyzed casein infant formula

Intervention Type OTHER

Mother's own breast milk

Group Type OTHER

Mother's own breast milk

Intervention Type OTHER

Interventions

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Amino acid based infant formula

Intervention Type OTHER

Extensively hydrolyzed casein infant formula

Intervention Type OTHER

Mother's own breast milk

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Singleton, 1-7 days of age at registration or randomization
* Term infant with appropriate birth weight for gestational age
* Either solely formula fed or exclusively receiving mother's own breast milk
* Signed Informed Consent and Protected Health Information

Exclusion Criteria

* Caesarean delivery
* Infant was born from a mother with Type 1 diabetes
* History of underlying metabolic or chronic disease or immunocompromised
* Feeding difficulties or history of formula or human milk intolerance
* Signs of acute infection of current use of antibiotics

Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes