Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT05553743
Status
Recruiting
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Conditions

  • Antibiotics
  • Breastfeeding
  • COVID-19 Infection
  • COVID-19 Vaccine
  • Remdesivir

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • COVID-19 Exposure — BIOLOGICAL
    Have been or may have been exposed to COVID-19.
  • Antibiotic — DRUG
    Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.

Study Details

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.

Key Dates

Start date
Mar 27, 2014
Status verified
Dec 2024
Primary completion
Mar 31, 2040
Completion
Mar 31, 2040

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Human Milk Repository [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
Christina Chambers, PhD, MPH

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