Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COVID-19 Exposure, Antibiotic.
- Who it may be relevant to
- Registry conditions: Breastfeeding, COVID-19 Infection, COVID-19 Vaccine, Remdesivir. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The UCSD Human Milk Biorepository
Overview
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.
Interventions
- 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.
Primary outcome measures
- Human Milk Repository [Time frame: 1 year]
- Develop, maintain and manage the Repository [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (3)
- Sub-study 100: COVID-19 Exposure [Time frame: Through study completion, an average of 2 years]
- Sub-study 101: Antibiotic Exposure [Time frame: Through study completion, an average of 2 years]
- Sub-study 102: P50 MPRINT Admin Supplement [Time frame: Through study completion, an average of 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of California, San Diego — San Diego
Publications
- 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. PMID 36454186
Identifiers
NCT: NCT05553743 · 130658