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

NCT03123874 | Completed Results FDA Device

• 3 other identifiers: IRB #: 16080065662T32DK007158-42NYC-399436
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

human milk; breast milk; expressed human milk; bacterial communities; microbiome; breast pump; bacterial growth

Outcome Measures

Primary Outcomes (3)

• Bacterial Community Richness

  Richness is the total number of different bacterial taxa detected in the sample. This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.

  0 days after pumping

• Bacterial Community Diversity

  Bacterial community diversity will be assessed using the the Shannon diversity index. The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p\_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p\_i log(p\_i). This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.

  0 days after pumping

• Total Live Aerobic Bacterial Counts

  Number of live total aerobic bacteria in milk assessed by aerobic culturing of milk on plate count agar. Reported as colony-forming units (CFU)/mL.

  0 days after pumping

Study Arms (2)

Sterile pump set-up first

EXPERIMENTAL

Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.

Device: Sterile pump set-up; Device: Mother's Own pump set-up

Mother's Own pump set-up first

EXPERIMENTAL

Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.

Device: Sterile pump set-up; Device: Mother's Own pump set-up

Interventions

Sterile pump set-up DEVICE

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

Mother's Own pump set-up first; Sterile pump set-up first

Mother's Own pump set-up DEVICE

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

Mother's Own pump set-up first; Sterile pump set-up first

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Cornell University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Idaho: collaborator
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

Hay Laboratory, B75C Wing Hall, Cornell University

Ithaca, New York, 14853, United States

Location

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior

Results Point of Contact

• Title: Sarah Reyes
• Organization: Cornell University

smr296@cornell.edu

208-921-4967

Study Officials

• Kathleen M. Rasmussen, ScD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Anthony Hay, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Sarah Reyes, MS

  Cornell University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will pump their milk with two pump set-ups: own and sterile supplies. The pump set-up each woman used first was randomized according to infant feeding status (human milk only vs. human milk and complementary foods).

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 21, 2017
• Study Start: May 22, 2017
• Primary Completion: October 2, 2017
• Study Completion: October 2, 2017
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)