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

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT05553743

Collaborator

(none)

5,000

Enrollment

Location

311.2

Anticipated Duration (Months)

16.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding COVID-19 Infection COVID-19 Vaccine Remdesivir Antibiotics	Biological: COVID-19 Exposure Drug: Antibiotic

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The UCSD Human Milk Biorepository

Actual Study Start Date :

Mar 27, 2014

Anticipated Primary Completion Date :

Mar 1, 2040

Anticipated Study Completion Date :

Mar 1, 2040

Arms and Interventions

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

Arm

Intervention/Treatment

Main Study

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

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

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

Sub-study 101: Antibiotic Exposure

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

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

Outcome Measures

Primary Outcome Measures

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

Sub-study 100: COVID-19 Exposure [Ongoing]
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 [Ongoing]
Determine the pharmacokinetics of commonly used antibiotics (e.g., azithromycin, amoxicillin and clavulanic acid, amoxicillin or nitrofurantoin) in human milk samples.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego	San Diego	California	United States	92093

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator: Christina Chambers, PhD, MPH, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christina Chambers, Professor, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT05553743

Other Study ID Numbers:

130658

First Posted:

Sep 23, 2022

Last Update Posted:

Sep 23, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christina Chambers, Professor, University of California, San Diego

Additional relevant MeSH terms:

COVID-19

Anti-Bacterial Agents

Study Results

No Results Posted as of Sep 23, 2022