A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France Using the Stool Tracker (an Image Recognition AI for Automated Stool Consistency Detection)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Distribution of infant stool consistency scores in France (BITSS).
研究概览
简要总结
The objective of this study is to investigate the influence of various factors (e.g. diet) on the stool consistency of infants in France.
详细描述
The main objective of this study is to investigate the distribution of infant stool consistency in France in a real-world context and assess variables that are potentially associated with stool consistency. The study will involve real-world data collection via a survey. Caregiver(s) are approached/reached via social media. Caregiver(s) enter retrospective (e.g., demographics, feeding history) and current data (e.g., diet, health status), along with uploading data and images on their infant's stool. Caregivers can upload data and images as often as they want to, until their infant reaches the age of 6 months. Stool consistency will evaluated both via parent reported BITSS as well as via the Stool Tracker AI module.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 0 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •French infants with an age between 0-6 months
排除标准
- •Non-French infants • Infants > 6 months of age
结局指标
主要结局
Distribution of infant stool consistency scores in France (BITSS).
时间窗: 1-3 days
Assessment of the association between different factors/variables and stool consistency scores, including demographics, diet/feeding history (exclusively breast-fed, formula-fed, mixed-fed), infant formula type, recent antibiotic use amongst others.
次要结局
未报告次要终点