Health TrialsbyHealthPanel

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

ConditionsBreastfeedingCOVID-19 InfectionCOVID-19 VaccineRemdesivirAntibiotics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women who are 18 years old or older

Breastfeeding

Producing sufficient breast milk to donate an excess to the Biorepository

Disqualifiers

Women under 18 years old

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • COVID-19 Exposure

    Biological/Vaccine

    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.

Treatment groups

5,000 Participants
are divided into 4 treatment groups
Group A: Main Study0 interventions
Group B: Sub-study 100: COVID-19 Exposure1 intervention
Group C: Sub-study 101: Antibiotic Exposure1 intervention
Group D: Sub-study 102: P50 MPRINT Admin Supplement0 interventions

Trial outcomes

Primary outcomes

1

Human Milk Repository

Establish a human milk repository at UCSD

Time frame
1 year
2

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.

Time frame
Through study completion, an average of 2 years

Secondary outcomes

1

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.

Time frame
Through study completion, an average of 2 years
2

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.

Time frame
Through study completion, an average of 2 years
3

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.

Time frame
Through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
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