BreastfeedingNCT05553743
Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
An observational study of Breastfeeding and COVID-19 Infection, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health. 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
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine
- What is being tested?
- COVID-19 Exposure and Antibiotic
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2014to Mar 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Any woman who is 18 or older, interested in participating, and is producing sufficient breast milk to donate an excess to the Biorepository will be invited to participate. We may enroll breastfeeding women who are pregnant or women who are pregnant and intend to breastfeed upon birth. We will not exclude any breastfeeding woman based on age (as long as above the legal age of consent), medical condition, or any other factor. Women will not be excluded based on exposures or lack thereof. We are currently enrolling women who have been or are exposed to: * Prescription Medications * SSRIs * Monoclonal Antibody Medications (mABS) * All other Rx medications * Women residing in Southern CA with a baby <6 months of age * Marijuana
Who may be able to join
- Women who are 18 years old or older
- Breastfeeding
- Producing sufficient breast milk to donate an excess to the Biorepository
Who cannot join
- Women under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92093
Christina Chambers, PhD, MPH
About this study
Official title: The UCSD Human Milk Biorepository
The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.
Read the detailed description
Participants in this study will participate in the following:
- Provide a milk sample: If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon.
- Answer questions about participant's health: Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history.
- Fill out online questionnaires about participant's eating habits and mood: The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods. The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether.
- The investigators will store the participant's sample and information in the Human Milk Biorepository: The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them.
- The investigators will let researchers use the stored materials for approved research studies: Researchers can apply to study the samples and information stored in the Human Milk Biorepository.
- If the participant agrees, the investigators may contact the participant with information about other research studies.
- Conditions
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir, Antibiotics
- Being tested
- COVID-19 Exposure, Antibiotic
- Keywords
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir, Antibiotics
- Medical subject headings
- Breast Feeding, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 ExposureBiological
Have been or may have been exposed to COVID-19.
AntibioticDrug
Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
| Study group | Role | What they receive |
|---|---|---|
| Main Study | The purpose of this project is to collect and store breast milk samples and health information about moms and their babies in a Human Milk Biorepository at UCSD. Through these studies, researchers hope to understand more about the benefits of breast milk, and how it prevents or treats child health problems. | |
| Sub-study 100: COVID-19 Exposure | The purpose of this substudy is to learn how exposures to COVID-19 and breastfeeding may affect the development of the child. Women who contact the UCSD Human Milk Biorepository will be screened for possible COVID-19 infection or exposure. Women will be eligible to enroll in the COVID-19 sub-study if they are confirmed positive, are presumptive positive, are symptomatic but not tested, or have confirmed exposure but are asymptomatic. Receives: Biological: COVID-19 Exposure | |
| Sub-study 101: Antibiotic Exposure | The purpose of this substudy is to learn more about maternal use of antibiotics in women who do or do not breastfeed, and how this may influence infant and child health. Women who contact or are referred to the UCSD Human Milk Biorepository will be screened to participate in the Antibiotic Exposure sub-study. Women will be eligible to enroll in the Antibiotic Exposure sub-study if they are 18 years of age or older, have a singleton infant who is <3 months of age at the time of recruitment, and agree to all requirements of the study. Receives: Drug: Antibiotic | |
| Sub-study 102: P50 MPRINT Admin Supplement | The purpose of this substudy is to review maternal medical exposure and how that may impact various components of human milk, the bacteria in the breastfed infant's gut, and the overall health and development of the breastfeeding child. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Milk Repository
Establish a human milk repository at UCSD
Measured: 1 year
Develop, maintain and manage the Repository
Develop, maintain and manage the Repository as a resource for investigators to conduct research on the health characteristics and benefits of human breast milk.
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Sub-study 100: COVID-19 Exposure
Develop, maintain and manage collection of other specimens for evidence of exposure to SARS-CoV-2, the virus responsible for COVID-19 disease.
Measured: Through study completion, an average of 2 years
Sub-study 101: Antibiotic Exposure
Determine the pharmacokinetics of commonly used antibiotics (e.g., azithromycin, amoxicillin and clavulanic acid, amoxicillin or nitrofurantoin) in human milk samples.
Measured: Through study completion, an average of 2 years
Sub-study 102: P50 MPRINT Admin Supplement
Expand enrollment in the UC San Diego human milk research biorepository to include 300 new participants who will provide milk samples paired with maternal and infant blood, stool, skin swabs, and maternal saliva.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start27 Mar 2014
- Primary completionMar 2040 (estimated)
- Study completionMar 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Chambers, University of California, San Diego
- Investigators
- Christina Chambers, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553743
- Sponsor's protocol ID
- 130658
- Status last verified
- Dec 2024
- First submitted
- 19 Sep 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertrand K, Kelly A, Chambers CD. The Prevalence of Nonserious Events in a Cohort of Breastfed Infants. Breastfeed Med. 2023 Jan;18(1):43-47. doi: 10.1089/bfm.2022.0245. Epub 2022 Nov 28.
PubMed 36454186
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UCSD Human Milk Biorepository
- ClinicalTrials.gov ID
- NCT05553743
- Acronym / sponsor ID
- 130658
- Conditions
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir, Antibiotics
- Keywords
- Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir, Antibiotics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 27 Mar 2014 (actual)
- Primary completion
- Mar 2040 (estimated)
- Study completion
- Mar 2040 (estimated)
- First posted
- 23 Sep 2022 (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.
The purpose of the UCSD Human Milk Biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.
Detailed description
Participants in this study will participate in the following:
- Provide a milk sample: If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon.
- Answer questions about participant's health: Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history.
- Fill out online questionnaires about participant's eating habits and mood: The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods. The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether.
- The investigators will store the participant's sample and information in the Human Milk Biorepository: The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them.
- The investigators will let researchers use the stored materials for approved research studies: Researchers can apply to study the samples and information stored in the Human Milk Biorepository.
- If the participant agrees, the investigators may contact the participant with information about other research studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Main Study | – | –The purpose of this project is to collect and store breast milk samples and health information about moms and their babies in a Human Milk Biorepository at UCSD. Through these studies, researchers hope to understand more about the benefits of breast milk, and how it prevents or treats child health problems. |
| Sub-study 100: COVID-19 Exposure | – | Biological: COVID-19 ExposureThe purpose of this substudy is to learn how exposures to COVID-19 and breastfeeding may affect the development of the child. Women who contact the UCSD Human Milk Biorepository will be screened for possible COVID-19 infection or exposure. Women will be eligible to enroll in the COVID-19 sub-study if they are confirmed positive, are presumptive positive, are symptomatic but not tested, or have confirmed exposure but are asymptomatic. |
| Sub-study 101: Antibiotic Exposure | – | Drug: AntibioticThe purpose of this substudy is to learn more about maternal use of antibiotics in women who do or do not breastfeed, and how this may influence infant and child health. Women who contact or are referred to the UCSD Human Milk Biorepository will be screened to participate in the Antibiotic Exposure sub-study. Women will be eligible to enroll in the Antibiotic Exposure sub-study if they are 18 years of age or older, have a singleton infant who is <3 months of age at the time of recruitment, and agree to all requirements of the study. |
| Sub-study 102: P50 MPRINT Admin Supplement | – | –The purpose of this substudy is to review maternal medical exposure and how that may impact various components of human milk, the bacteria in the breastfed infant's gut, and the overall health and development of the breastfeeding child. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any woman who is 18 or older, interested in participating, and is producing sufficient breast milk to donate an excess to the Biorepository will be invited to participate. We may enroll breastfeeding women who are pregnant or women who are pregnant and intend to breastfeed upon birth. We will not exclude any breastfeeding woman based on age (as long as above the legal age of consent), medical condition, or any other factor. Women will not be excluded based on exposures or lack thereof. We are currently enrolling women who have been or are exposed to: * Prescription Medications * SSRIs * Monoclonal Antibody Medications (mABS) * All other Rx medications * Women residing in Southern CA with a baby <6 months of age * Marijuana
Key inclusion criteria (3 listed)
- Women who are 18 years old or older
- Breastfeeding
- Producing sufficient breast milk to donate an excess to the Biorepository
Key exclusion criteria (1 listed)
- Women under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 ExposureHave been or may have been exposed to COVID-19. | Biological | Sub-study 100: COVID-19 Exposure |
| AntibioticHave or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin. | Drug | Sub-study 101: Antibiotic Exposure |
Primary outcome
Human Milk Repository
Time frame: 1 year
Establish a human milk repository at UCSD
Develop, maintain and manage the Repository
Time frame: Through study completion, an average of 2 years
Develop, maintain and manage the Repository as a resource for investigators to conduct research on the health characteristics and benefits of human breast milk.
3 secondary outcomes
Sub-study 100: COVID-19 Exposure
Time frame: Through study completion, an average of 2 years
Sub-study 101: Antibiotic Exposure
Time frame: Through study completion, an average of 2 years
Sub-study 102: P50 MPRINT Admin Supplement
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 36454186Bertrand K, Kelly A, Chambers CD. The Prevalence of Nonserious Events in a Cohort of Breastfed Infants. Breastfeed Med. 2023 Jan;18(1):43-47. doi: 10.1089/bfm.2022.0245. Epub 2022 Nov 28.
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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.
Christina Chambers, PhD, MPH principal investigator
University of California, San Diego
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 Breastfeeding and COVID-19 Infection, run by University of California, San Diego 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 3 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Chambers, PhD, MPH (858-246-1793, chchambers@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Milk Repository (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05553743, which also lists 1 linked publication.
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 31 Jan 2025.