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

Summary

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.

Conditions

• Human Milk Microbiome
• Bacterial Growth

Interventions

DEVICE

Sterile pump set-up

Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).

DEVICE

Mother's Own pump set-up

Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).

Sponsors & Collaborators

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

  collaborator NIH

• University of Idaho

  collaborator OTHER

• United States Department of Agriculture (USDA)

  collaborator FED

• Cornell University

  lead OTHER

Principal Investigators

• Kathleen M. Rasmussen, ScD · Cornell University

• Anthony Hay, PhD · Cornell University

• Sarah Reyes, MS · Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-22

Primary Completion

2017-10-02

Completion

2017-10-02

FDA Device

Yes

Countries

• United States

Study Locations