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

Completed

• Conditions: Bacterial Communities

• Registration Number: NCT03371511
• Lead Sponsor: Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-10
• Primary Completion: 2017-09-03
• Study Completion: 2017-09-03
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

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

Exclusion Criteria

• Anyone who did not participate in the MiLC Trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hay Laboratory, B75C Wing Hall, Cornell University; 🇺🇸 Ithaca, New York, United States