Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
NCT ID: NCT05553743
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
5000 participants
OBSERVATIONAL
2014-03-27
2040-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
COVID-19 and Lactating Mothers
NCT04558320
Antibody Detection of Vaccine-Induced Secretory Effects
NCT04895475
The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development
NCT04434027
Study of the Breast Milk Microbiota and Its Influence on the Development of Early and Late Neonatal Bacterial Sepsis Under Three Months of Age.
NCT05490498
The Influence of Mother Nutrition on Breast Milk Microbiome
NCT02332382
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
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.
Antibiotic
Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
Sub-study 102: P50 MPRINT Admin Supplement
The purpose of this substudy is to review maternal medical exposure and how that may impact various components of human milk, the bacteria in the breastfed infant's gut, and the overall health and development of the breastfeeding child.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
COVID-19 Exposure
Have been or may have been exposed to COVID-19.
Antibiotic
Have or have not been prescribed one of several commonly used antibiotics including azithromycin, amoxicillin and clavulanic acid, amoxicillin, or nitrofurantoin.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Breastfeeding
* Producing sufficient breast milk to donate an excess to the Biorepository
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Christina Chambers
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christina Chambers, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christina Chambers, PhD, MPH
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Bertrand K, Kelly A, Chambers CD. The Prevalence of Nonserious Events in a Cohort of Breastfed Infants. Breastfeed Med. 2023 Jan;18(1):43-47. doi: 10.1089/bfm.2022.0245. Epub 2022 Nov 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
130658
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.