Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial

Cornell University52 enrolled

Overview

This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier: NCT03123874). Our objective is to characterize the bacterial communities of women's breasts, hands, their pump and milk collection kit, and their babies' mouths among the participants of the MiLC Trial. As part of the original protocol, we collected swabs of each of these areas from each dyad before women pumped with their own pumps. By characterizing these communities, we can identify from where the bacteria in human milk (HM) originates, and determine whether pumping with mother's own pumps enriches the bacterial communities of HM compared to pumping with a sterile pump.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bacterial Communities

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Mother-infant dyads who participated in the MiLC Trial. Exclusion Criteria: * Anyone who did not participate in the MiLC Trial.

Locations (1)

Hay Laboratory, B75C Wing Hall, Cornell University

Ithaca, New York, United States

Outcomes

Primary Outcomes

Bacterial communities

Bacterial communities of each swab (breast, hand, mother's own bottle/flange, mother's own pump/tubing, and infant mouth) will be determined by next-generation sequencing of the V1-V3 region of the 16S rRNA bacterial gene.

Time frame: 0 days after pumping