Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions

Completed · Not applicable

Conditions studied: Human Milk Microbiome, Bacterial Growth

In brief

The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life" conditions. To meet this objective, lactating mothers will fully express breast milk from one breast on two consecutive pumping sessions at home, once with the participant's own pumps and collection kits (own pump set-up) and once with a hospital-grade pump and disposable, sterile collection kits (sterile pump set-up). Randomization will be used to determine which pump participants use first. From the total volume of milk pumped during each pumping session, the researchers will collect 1 oz. Milk from both pumps will be stored at home and sampled on days 0, 2, 4, and 30 after expression for analysis of its bacterial composition.

Key facts

Study ID

NCT03123874

Run by

Cornell University

People needed

52

Starts

2017-05-22

Expected to finish

2017-10-02

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Lactating women over the age of 18 years
• Self-reported as healthy women and infants
• Use an electric breast pump
• Confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions where pumping sessions are 3 hours (+/- 30 minutes) apart and between 0700-1100 hours.
• Able to store donated milk at home for 30 days
• Have infants who do not consume formula or only consume formula episodically as long as the most recent formula-feeding occurred > 2 weeks before the day milk is pumped for this study.

You may not qualify if…

• Not confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions, 3 hours (+/- 30 minutes) apart and between the hours of 0700-1100 hours.
• Infant consumption of formula in the past 2 weeks
• Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
• Breast pain that the woman does not consider "normal" for lactation/breastfeeding
• Signs/symptoms of acute illness in woman or infant in past 7 days including fever (rectal or temporal temperature ≥99.5 F), dark green nasal discharge, diarrhea (abrupt onset of 3 or more excessively "loose" stools in one day), vomiting (where infant vomiting is not associated with feeding), or severe cough.

Where it is running

• Hay Laboratory, B75C Wing Hall, Cornell University — Ithaca, New York, United States

Full record on ClinicalTrials.gov

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