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

Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03371511

Enrollment

Registered

2017-12-13

Start date

2017-06-10

Completion date

2017-09-03

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Communities

Keywords

Microbiota, Microbiome

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Mother-infant dyads who participated in the MiLC Trial.

Exclusion criteria

* Anyone who did not participate in the MiLC Trial.

Design outcomes

Primary

Measure	Time frame	Description
Bacterial communities	0 days after pumping	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.

Countries

United States

Outcome results