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NCT Number: NCT05553743

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

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.

Recruiting

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Key information

Conditions

Breastfeeding Antibiotics Behavior Breast Feeding COVID-19 COVID-19 Infection COVID-19 Vaccine Coronaviridae Infections Coronavirus Infections Feeding Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Remdesivir Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Location status: Recruiting

Location contact

Christina Chambers, PhD, MPH

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 Exposure

Biological

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

Antibiotic

Drug

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

Primary outcomes

  1. Human Milk Repository

    Time frame: 1 year

    Establish a human milk repository at UCSD

  2. Develop, maintain and manage the Repository

    Time frame: 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 outcomes

  1. Sub-study 100: COVID-19 Exposure

    Time frame: 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.

  2. Sub-study 101: Antibiotic Exposure

    Time frame: 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.

  3. Sub-study 102: P50 MPRINT Admin Supplement

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Chambers, PhD, MPH

CONTACT

[email protected]

858-246-1793

Kerri Bertrand

CONTACT

[email protected]

858-246-1713

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

The UCSD Human Milk Biorepository

Important dates

Study start
2014
Primary completion
2040
Study completion
2040
First posted
Sep 23, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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