The UCSD Human Milk Biorepository
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Human Milk Repository
研究概览
简要总结
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.
详细描述
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. 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are 18 years old or older
- •Breastfeeding
- •Producing sufficient breast milk to donate an excess to the Biorepository
排除标准
- •Women under 18 years old
研究组 & 干预措施
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.
干预措施: COVID-19 Exposure (Biological)
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.
干预措施: Antibiotic (Drug)
结局指标
主要结局
Human Milk Repository
时间窗: 1 year
Establish a human milk repository at UCSD
Develop, maintain and manage the Repository
时间窗: 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.
次要结局
- Sub-study 100: COVID-19 Exposure(Through study completion, an average of 2 years)
- Sub-study 101: Antibiotic Exposure(Through study completion, an average of 2 years)
- Sub-study 102: P50 MPRINT Admin Supplement(Through study completion, an average of 2 years)
研究者
Christina Chambers
Professor
University of California, San Diego