Antibiotics, Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir
Conditions
Keywords
Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir, Antibiotics
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.
Detailed description
Participants in this study will participate in the following: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. If the participant agrees, the investigators may contact the participant with information about other research studies.
Interventions
BIOLOGICALCOVID-19 Exposure
Have been or may have been exposed to COVID-19.
DRUGAntibiotic
Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Milk Repository | 1 year | Establish a human milk repository at UCSD |
| Develop, maintain and manage the Repository | Through study completion, an average of 2 years | Develop, maintain and manage the Repository as a resource for investigators to conduct research on the health characteristics and benefits of human breast milk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sub-study 100: COVID-19 Exposure | Through study completion, an average of 2 years | Develop, maintain and manage collection of other specimens for evidence of exposure to SARS-CoV-2, the virus responsible for COVID-19 disease. |
| Sub-study 101: Antibiotic Exposure | Through study completion, an average of 2 years | Determine the pharmacokinetics of commonly used antibiotics (e.g., azithromycin, amoxicillin and clavulanic acid, amoxicillin or nitrofurantoin) in human milk samples. |
| Sub-study 102: P50 MPRINT Admin Supplement | Through study completion, an average of 2 years | 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. |
Countries
United States
Contacts
Primary ContactChristina Chambers, PhD, MPH
Backup ContactKerri Bertrand
Outcome results
None listed