Bacterial CommunitiesNCT03371511
Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial
An observational study of Bacterial Communities, run by Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Communities
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2017to 3 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Mother-infant dyads who participated in the MiLC Trial.
Who cannot join
- Anyone who did not participate in the MiLC Trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hay Laboratory, B75C Wing Hall, Cornell University
Ithaca, New York, 14853
About this study
Official title: Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial
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.
- Conditions
- Bacterial Communities
- Keywords
- Microbiota, Microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial communities
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.
Measured: 0 days after pumping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start10 Jun 2017
- Primary completion3 Sep 2017
- Study completion3 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial CommunitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Idaho
- Responsible party
- Sponsor
- Investigators
- Sarah M Reyes, MS, Study director, Cornell UniversityKathleen M Rasmussen, ScD, Principal investigator, Cornell UniversityAnthony G Hay, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371511
- Sponsor's protocol ID
- 1608006566
- Other IDs
- 2T32DK007158-42
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2017
- Last updated
- 14 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial
- ClinicalTrials.gov ID
- NCT03371511
- Acronym / sponsor ID
- 1608006566
- Conditions
- Bacterial Communities
- Keywords
- Microbiota, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Idaho
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 3 Sep 2017 (actual)
- Study completion
- 3 Sep 2017 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Mother-infant dyads who participated in the MiLC Trial.
Key exclusion criteria (1 listed)
- Anyone who did not participate in the MiLC Trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M Reyes, MS study director
Cornell University
Kathleen M Rasmussen, ScD principal investigator
Cornell University
Anthony G Hay, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Communities, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial communities (time frame: 0 days after pumping). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.