Clinical trial

The UCSD Human Milk Biorepository

Name

130658

Description

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 arms

Trial start

2014-03-27

Estimated PCD

2040-03-01

Trial end

2040-03-01

Status

Recruiting

Treatment

COVID-19 Exposure

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

Arms:

Sub-study 100: COVID-19 Exposure

Antibiotic

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

Arms:

Sub-study 101: Antibiotic Exposure

Size

5000

Primary endpoint

Human Milk Repository

1 year

Develop, maintain and manage the Repository

Through study completion, an average of 2 years

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The following samples may be collected:\n\n* Human Milk\n* Deciduous teeth from your breastfed children\n* Saliva Samples\n* Nostril Swabs\n* Stool Samples\n* Blood Samples (finger-prick)\n* Home Environmental Swabs'}, 'enrollmentInfo': {'count': 5000, 'type': 'ESTIMATED'}}

Updated at

2023-11-08

1 organization

2 products

5 indications

Organization

University of California, San Diego

Product

COVID-19 Exposure

Indication

Breastfeeding

Indication