Clinical trial NCT05553743: Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
Official title: The UCSD Human Milk Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breastfeeding
COVID-19 Infection
COVID-19 Vaccine
Remdesivir
Antibiotics
Keywords: Breastfeeding
COVID-19 Infection
COVID-19 Vaccine
Remdesivir
Antibiotics
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any woman who is 18 or older, interested in participating, and is producing sufficient breast milk to donate an excess to the Biorepository will be invited to participate. We may enroll breastfeeding women who are pregnant or women who are pregnant and intend to breastfeed upon birth. We will not exclude any breastfeeding woman based on age (as long as above the legal age of consent), medical condition, or any other factor.

Women will not be excluded based on exposures or lack thereof. We are currently enrolling women who have been or are exposed to:

* Prescription Medications

  * SSRIs
  * Monoclonal Antibody Medications (mABS)
  * All other Rx medications
* Women residing in Southern CA with a baby \<6 months of age
* Marijuana

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Human Milk Repository
timeFrame: 1 year
measure: Develop, maintain and manage the Repository
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Sub-study 100: COVID-19 Exposure
timeFrame: Through study completion, an average of 2 years
measure: Sub-study 101: Antibiotic Exposure
timeFrame: Through study completion, an average of 2 years
measure: Sub-study 102: P50 MPRINT Admin Supplement
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Christina Chambers, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: