My Baby Biome: Infant Stool Samples for Microbiome Health (MBB)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Determine the composition of a healthy infant microbiome
研究概览
简要总结
My Baby Biome is an observational study that will use 600 infant stool samples to determine the biomarkers associated with a healthy infant gut. Biomarkers identified in this study will be used to develop precision probiotics and LBPs for improving infant gut health outcomes to the benefit of all infants. Parents will be asked to submit follow-up questionnaires regarding infant immune health to improve insights obtained from the data.
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
- 0 Months 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Infants under 2 weeks or over 2 months old
- •Infants given any antibiotic or probiotic treatments
- •Infants delivered prematurely or admitted to the NICU outside of establishment of normal feeding
- •Infants with mothers under the age of 18
- •Infants with mothers known to have HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV2
排除标准
- 未提供
结局指标
主要结局
Determine the composition of a healthy infant microbiome
时间窗: 6-12 Months
Stool samples will be analyzed for bacterial metagenomics, metabolomics, proteomics, and transcriptomics to define biomarkers (such as bacteria or proteins) that are correlated with healthy infants as defined by the accompanying questionnaire.
次要结局
- Evaluate impact of the microbiome on immune adverse events(7 Years)
- Build a library of samples and data for future research(6-12 Months)