Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial
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|ClinicalTrials.gov Identifier: NCT03371511|
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : January 14, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial|
|Actual Study Start Date :||June 10, 2017|
|Actual Primary Completion Date :||September 3, 2017|
|Actual Study Completion Date :||September 3, 2017|
Participants donated HM from two consecutive pumping sessions at home. Women pumped once with their own pump and milk collection kit, and once with a sterile and sterile collection kit. Both pumping sessions occurred at participants' homes between 0700 and 1100 hours. The second pumping session occurred within 3 hr (+/- 30 min) after the beginning of the first. Randomization was used to determine which pump was used first. Women elected from which breast they donated their HM and were asked not to nurse on that side 2 hr before the first pumping session and not until after the second. Before women pumped with their own pump, swabs were taken of the breast from which HM was donated, the women's dominant hand, their own bottle/flange, their own pumps (port of pump and tubing), and their babies' mouths.
There was only one group but stratified enrollment was used to ensure equal numbers of women whose infants consumed HM only and women whose infants consumed HM and complementary foods.
- Bacterial communities [ Time Frame: 0 days after pumping ]Bacterial communities of each swab (breast, hand, mother's own bottle/flange, mother's own pump/tubing, and infant mouth) will be determined by next-generation sequencing of the V1-V3 region of the 16S rRNA bacterial gene.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371511
|United States, New York|
|Hay Laboratory, B75C Wing Hall, Cornell University|
|Ithaca, New York, United States, 14853|
|Study Director:||Sarah M Reyes, MS||Cornell University|
|Principal Investigator:||Kathleen M Rasmussen, ScD||Cornell University|
|Principal Investigator:||Anthony G Hay, PhD||Cornell University|