Trial Outcomes & Findings for Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions (NCT NCT03123874)

Last Updated: 2019-05-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

0 days after pumping

Results posted on

2019-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Sterile Pump Set-up First Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.	Mother's Own Pump Set-up First Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
Overall Study STARTED	27	25
Overall Study COMPLETED	27	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sterile Pump Set-up First n=27 Participants Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.	Mother's Own Pump Set-up First n=25 Participants Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33.6 years STANDARD_DEVIATION 4.1 • n=5 Participants	33.6 years STANDARD_DEVIATION 4.0 • n=7 Participants	33.6 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/white	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized African American/black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	25 participants n=7 Participants	52 participants n=5 Participants
Infant feeding status, number fed human milk only	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 days after pumping

Population: Data analyzed for all participants

Outcome measures

Outcome measures
Measure	Sterile Pump Set-up First n=27 Participants Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.	Mother's Own Pump Set-up First n=25 Participants Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
Bacterial Community Richness In Milk Collected with Sterile Pump Set-Up	64.2 Observed taxa Standard Deviation 38.3	58.9 Observed taxa Standard Deviation 26.9
Bacterial Community Richness In Milk Collected with Mother's Own Pump Set-Up	64.0 Observed taxa Standard Deviation 30.7	60.8 Observed taxa Standard Deviation 32.8

PRIMARY outcome

Timeframe: 0 days after pumping

Population: Data analyzed from all participants.

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.

Outcome measures

Outcome measures
Measure	Sterile Pump Set-up First n=27 Participants Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.	Mother's Own Pump Set-up First n=25 Participants Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
Bacterial Community Diversity In Milk Collected with Sterile Pump Set-Up	3.89 Shannon Diversity Index Standard Deviation 1.18	3.56 Shannon Diversity Index Standard Deviation 1.13
Bacterial Community Diversity In Milk Collected with Mother's Own Pump Set-Up	3.84 Shannon Diversity Index Standard Deviation 1.08	3.93 Shannon Diversity Index Standard Deviation 1.26

PRIMARY outcome

Timeframe: 0 days after pumping

Population: Data for all participants analyzed.

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.

Outcome measures

Outcome measures
Measure	Sterile Pump Set-up First n=27 Participants Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups.	Mother's Own Pump Set-up First n=25 Participants Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
Total Live Aerobic Bacterial Counts In Milk Collected with Sterile Pump Set-Up	1848 Colony-forming units (CFU)/mL Standard Deviation 734	1233 Colony-forming units (CFU)/mL Standard Deviation 490
Total Live Aerobic Bacterial Counts In Milk Collected with Mother's Own Pump Set-Up	9157 Colony-forming units (CFU)/mL Standard Deviation 3638	6109 Colony-forming units (CFU)/mL Standard Deviation 2427

Adverse Events

Sterile Pump Set-up First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mother's Own Pump Set-up First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Reyes

Cornell University

Phone: 208-921-4967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place