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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05553743
Other study ID # 130658
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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