Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Microbiome Activity Index
研究概览
简要总结
The goal of this observational study is to quantify the typical frequency of flatulence in healthy adults, normalized by fiber intake, using the Smart Underwear device. The study will enroll a maximum of 500 adults across the United States who will wear the device for three consecutive days while continuing their usual daily activities.
The main questions it aims to answer are:
- What is the average frequency of flatus events in a general adult population?
- How does dietary fiber intake influence flatus frequency and microbiome activity?
Researchers will collect gas sensor data from the Smart Underwear device alongside dietary information logged in a mobile app to assess the relationship between diet and microbiome activity.
Participants will:
- Complete an online eligibility survey, consent form, and background questionnaire.
- Wear the Smart Underwear device for at least 12 hours per day for three consecutive days.
- Log all meals with photos using a custom smartphone app.
- Complete a short post-wear survey about device comfort and usability.
All study procedures will be conducted remotely. Data will be analyzed in de-identified form to evaluate baseline flatulence patterns, normalized to fiber intake, in the general adult population.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years old or older
- •Lives in the US
- •Is not pregnant or lactating
- •Is willing to wear the Smart Underwear device as instructed in the study procedures
排除标准
- •Younger than 18 years old
- •Lives outside the US
- •Is pregnant or lactating
- •Is not willing to wear the Smart Underwear device as instructed in the study procedures
结局指标
主要结局
Microbiome Activity Index
时间窗: 12 hours each day for 3 days
The Microbiome Activity Index is a composite measure reflecting gut microbiome activity, calculated from both flatus frequency and hydrogen gas concentration. The index uses the absolute value of the first derivative of the hydrogen sensor signal to better capture flatus intensity, reduce baseline noise, and mitigate sensor saturation at high hydrogen levels. This composite approach ensures a more accurate representation of gut microbiome activity than relying on flatus count or hydrogen concentration alone. Data are collected using a wearable device ("Smart Underwear") and uploaded to the Human Flatus Atlas app.
次要结局
- Fiber-Normalized Flatus Frequency(12 hours each day for 3 days)
- Total flatus count(12 hours each day for 3 days)
- Flatus Per Hour(12 hours each day for 3 days)
- Microbiome Activity Index Comparative Score(12 hours each day for 3 days)