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Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease
Bacterial Communities

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Group/Cohort
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.




Primary Outcome Measures :
  1. 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
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Lactating women
Accepts Healthy Volunteers:   Yes
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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Anyone who did not participate in the MiLC Trial.

Information from the National Library of Medicine

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


Locations
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United States, New York
Hay Laboratory, B75C Wing Hall, Cornell University
Ithaca, New York, United States, 14853
Sponsors and Collaborators
Cornell University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Idaho
Investigators
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Study Director: Sarah M Reyes, MS Cornell University
Principal Investigator: Kathleen M Rasmussen, ScD Cornell University
Principal Investigator: Anthony G Hay, PhD Cornell University
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT03371511    
Other Study ID Numbers: 1608006566
2T32DK007158-42 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
Microbiota
Microbiome