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Completed

NCT Number: NCT03371511

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

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.

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Key information

Conditions

Bacterial Communities

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hay Laboratory, B75C Wing Hall, Cornell University

Ithaca, New York, 14853, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Anyone who did not participate in the MiLC Trial.

Treatment and study plan

Primary outcomes

  1. Bacterial communities

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Idaho

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2017
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.