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

Recruiting

• Conditions: COVID-19 Vaccine; Remdesivir; Antibiotics; COVID-19 Infection; Breastfeeding
• Interventions: Biological: COVID-19 Exposure; Drug: Antibiotic

• Registration Number: NCT05553743
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2014-03-27
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-31
• Primary Completion: 2040-03
• Study Completion: 2040-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 5000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sub-study 100: COVID-19 Exposure	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	Antibiotic	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 San Diego, California, United States