Bacterial Growth Clinical Trial
— MiLCOfficial title:
Milk in Life Conditions (MiLC): Characterizing the Bacterial Composition of Human Milk Pumped and Stored in "Real-life" Conditions
Verified date | April 2019 |
Source | Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | October 2, 2017 |
Est. primary completion date | October 2, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hay Laboratory, B75C Wing Hall, Cornell University | Ithaca | New York |
Lead Sponsor | Collaborator |
---|---|
Cornell University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Food and Agriculture, University of Idaho |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 = -S 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 | |
Primary | 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 |
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