Gastrointestinal Tract Microbiome in Healthy Term Infants Receiving Mother'S-own Breast Milk or Cow's Milk-based Infant Formulas

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

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2022-02-02

Brief Summary

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This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.

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Detailed Description

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Conditions

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Gastrointestinal Microbiome

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

Cow's milk-based Infant Formula

Investigational

Group Type EXPERIMENTAL

Investigational

Intervention Type OTHER

Cow's milk-based Infant Formula with whey protein-lipid concentrate

Mother's-own Breast Milk

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Investigational

Cow's milk-based Infant Formula with whey protein-lipid concentrate

Intervention Type OTHER

Control

Cow's milk-based Infant Formula

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 7-18 days of age at Visit 1
* Singleton birth
* Gestational age of 37-42 weeks
* Birth weight of 2500 g (5 lbs 8 oz) or more
* Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
* Signed informed consent and use of PHI for infant and birth mother
* Receipt of three protocol-compliant Baseline stool samples

Infants receiving formula:

* Exclusively receiving infant formula for at least 24 hours prior to randomization
* Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period

Infants receiving human milk:

* Mother has intention to exclusively provide mother's-own breast milk for the duration of the study

Exclusion Criteria

* Caesarean delivery
* Infant consumption of donor milk prior to randomization/registration
* Maternal antibiotic use within 48 hours prior to or at time of delivery
* Maternal antibiotic use while providing mother's-own breast milk to infant
* Infant use of systemic antibiotics prior to randomization/registration
* Any signs of an acute infection (i.e. fever, diarrhea) at randomization/registration
* Weight at Visit 1 is \<95% of birth weight
* Infant use of probiotics
* Evidence of significant feeding difficulties
* Infant was born large for gestational age
* History of underlying metabolic or chronic disease or congenital malformation
* Infant is immunocompromised

Infants receiving human milk:

* Consumption of infant formula from 1 day of age

Minimum Eligible Age

7 Days

Maximum Eligible Age

18 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes