Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
The UCSD Human Milk Biorepository
1 other identifier
observational
5,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2014
CompletedFirst Submitted
Initial submission to the registry
September 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2040
January 31, 2025
December 1, 2024
25.9 years
September 19, 2022
January 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Human Milk Repository
Establish a human milk repository at UCSD
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.
Through study completion, an average of 2 years
Secondary Outcomes (3)
Sub-study 100: COVID-19 Exposure
Through study completion, an average of 2 years
Sub-study 101: Antibiotic Exposure
Through study completion, an average of 2 years
Sub-study 102: P50 MPRINT Admin Supplement
Through study completion, an average of 2 years
Study Arms (4)
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.
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.
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.
Interventions
Have been or may have been exposed to COVID-19.
Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
Eligibility Criteria
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
You may qualify if:
- Women who are 18 years old or older
- Breastfeeding
- Producing sufficient breast milk to donate an excess to the Biorepository
You may not qualify if:
- Women under 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Diego
San Diego, California, 92093, United States
Related Publications (1)
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.
PMID: 36454186DERIVED
Biospecimen
The following samples may be collected: * Human Milk * Deciduous teeth from your breastfed children * Saliva Samples * Nostril Swabs * Stool Samples * Blood Samples (finger-prick) * Home Environmental Swabs
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Chambers, PhD, MPH
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 19, 2022
First Posted
September 23, 2022
Study Start
March 27, 2014
Primary Completion (Estimated)
March 1, 2040
Study Completion (Estimated)
March 1, 2040
Last Updated
January 31, 2025
Record last verified: 2024-12