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

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants in this study will participate in the following: Provide a milk sample: If participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. The investigators will take as much as participants wish to donate, or as little as one teaspoon. Answer questions about participant's health: Future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. The investigators will ask participants for some contact information, health habits, and family's health history. Fill out online questionnaires about participant's eating habits and mood: The investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods. The investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. The questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. These questionnaires take about 30 minutes altogether. The investigators will store the participant's sample and information in the Human Milk Biorepository: The investigators will keep the participant's milk and health information in the Human Milk Biorepository. There is no limit on the length of time we will keep the milk and information. The investigators will keep them as long as they are useful, unless the participant asks to remove them. The investigators will let researchers use the stored materials for approved research studies: Researchers can apply to study the samples and information stored in the Human Milk Biorepository. If the participant agrees, the investigators may contact the participant with information about other research studies.

Official Title
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The UCSD Human Milk Biorepository

Conditions
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Remdesivir, Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Antibiotics

Intervention / Treatment
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* Biological: COVID-19 Exposure
* Drug: Antibiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Study<br>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<br>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. | Biological: COVID-19 Exposure<br>* Have been or may have been exposed to COVID-19.<br>|
| Sub-study 101: Antibiotic Exposure<br>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. | Drug: Antibiotic<br>* Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Ongoing | 
| 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. | Ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir, Antibiotics