Recruiting

Human Milk

Sponsor:

UCLA

Code:

NCT05553743

Conditions

Breastfeeding

COVID-19 Infection

COVID-19 Vaccine

Remdesivir

Antibiotics

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

COVID-19 Exposure

Antibiotic

Study Details

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.

Conditions

Breastfeeding

COVID-19 Infection

COVID-19 Vaccine

Remdesivir

Antibiotics

Study ID

NCT05553743

Start date

Mar 27, 2014

Status verified date

Dec, 2024

Completion date

Mar, 2040

Anticipated

Primary completion date

Mar, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Women who are 18 years old or older
  • Breastfeeding
  • Producing sufficient breast milk to donate an excess to the Biorepository

Exclusion Criteria:

  • Women under 18 years old

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

COVID-19 Exposure

Have been or may have been exposed to COVID-19.

Antibiotic

Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.

Primary outcome measure

  • Human Milk Repository [ Time Frame: 1 year ]
  • Develop, maintain and manage the Repository [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Christina Chambers, PhD, MPH

858-246-1793chchambers@ucsd.edu

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 31, 2025

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-01-31.