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

University of Maryland

Status: Enrolling

Conditions: All Health Backgrounds to Determine a Baseline of Flatus Activity

Study type: Observational

Funder types: Other

Identifiers

NCT07134543

Human Flatus Atlas

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

500 participants in 1 patient group

American adults

Description:

American 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.