NCT07134543

Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University of Maryland, College Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• All Health Backgrounds to Determine a Baseline of Flatus Activity

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-09-05
• Completion: 2026-12-01
• First posted: 2025-08-21
• Last updated: 2025-12-23

Locations

2 sites across 1 country: United States