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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
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Idaho
Information provided by (Responsible Party):
Cornell University

Tracking Information
First Submitted Date December 7, 2017
First Posted Date December 13, 2017
Last Update Posted Date January 14, 2019
Actual Study Start Date June 10, 2017
Actual Primary Completion Date September 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial
Official Title Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial
Brief Summary This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier: NCT03123874). Our objective is to characterize the bacterial communities of women's breasts, hands, their pump and milk collection kit, and their babies' mouths among the participants of the MiLC Trial. As part of the original protocol, we collected swabs of each of these areas from each dyad before women pumped with their own pumps. By characterizing these communities, we can identify from where the bacteria in human milk (HM) originates, and determine whether pumping with mother's own pumps enriches the bacterial communities of HM compared to pumping with a sterile pump.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Swabs were taken of women's dominant hand, the breast from which she donated milk (nipple, areola), their milk collection kit (bottle and flange), their pump (pump port and tubing), and their babies' mouths.
Sampling Method Non-Probability Sample
Study Population Mother-infant dyads who participated in the MiLC Trial. These were healthy, lactating women 18 years or older. Women had no signs of breast infection and self-reported that they nor their infants had signs/symptoms of acute illness 7 days before participating in the study. We also restricted participation to women who pumped with electric breast pumps, who could donate 1 oz of their milk on two consecutive pumping sessions from the same breast, and women whose infants had not consumed formula within the past 2 weeks. A full description of eligibility criteria can be found on the original protocol (ClinicalTrials.gov Identifier: NCT03123874).
Condition Bacterial Communities
Intervention Not Provided
Study Groups/Cohorts MiLC Cohort

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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 7, 2017)
52
Original Actual Enrollment Same as current
Actual Study Completion Date September 3, 2017
Actual Primary Completion Date September 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Mother-infant dyads who participated in the MiLC Trial.

Exclusion Criteria:

  • Anyone who did not participate in the MiLC Trial.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Lactating women
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03371511
Other Study ID Numbers 1608006566
2T32DK007158-42 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Cornell University
Study Sponsor Cornell University
Collaborators
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Idaho
Investigators
Study Director: Sarah M Reyes, MS Cornell University
Principal Investigator: Kathleen M Rasmussen, ScD Cornell University
Principal Investigator: Anthony G Hay, PhD Cornell University
PRS Account Cornell University
Verification Date January 2019