Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
Part of paid clinical trials in College Park, Maryland.
- Sponsor
- University of Maryland, College Park
- Study ID
- NCT07134543
- Status
- Recruiting
Conditions
- All Health Backgrounds to Determine a Baseline of Flatus Activity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Dec 2025
- Primary completion
- Sep 5, 2026
- Completion
- Dec 1, 2026
Study Design
- Enrollment
- 500 participants (estimated)
Arms
- Arm: American adultsAmerican adults that are at least 18 years old, live in the United States, are not pregnant or lactating, and agree to wear the Smart Underwear device.
Primary Outcome Measure
Microbiome Activity Index [ Time Frame: 12 hours each day for 3 days ]
Central Contacts
- Brantley Hall, PhD5407978040
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Bioscience Research Building | College Park | Maryland | 20742 | |
| University of Maryland Bioscience Research Building | College Park | Maryland | 20742 |