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

Breastfeeding Clinical Trial

Official title:

The UCSD Human Milk Biorepository

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553743
• Other study ID #: 130658
• Status: Recruiting
• Start date: March 27, 2014
• Est. completion date: March 2040

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: Christina Chambers, PhD, MPH
• Phone: 858-246-1793
• Email: chchambers[@]ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: March 2040
• Est. primary completion date: March 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotics
• Breastfeeding
• COVID-19
• COVID-19 Infection
• COVID-19 Vaccine
• Remdesivir

Intervention

Biological:
• COVID-19 Exposure
Have been or may have been exposed to COVID-19.

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

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Milk Repository	Establish a human milk repository at UCSD	1 year
Primary	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	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
Secondary	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