Recruiting

Observational Study

Sponsor:

University of Maryland, College Park

Code:

NCT07134543

Conditions

All Health Backgrounds to Determine a Baseline of Flatus Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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

Study ID

NCT07134543

Start date

Dec 1, 2025

Status verified date

Dec, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 5, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

American adults

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.

Primary outcome measure

  • Microbiome Activity Index [ Time Frame: 12 hours each day for 3 days ]

Central Contacts and Locations

Central contacts

Brantley Hall, PhD

5407978040brantley@umd.edu

Locations

University of Maryland Bioscience Research Building

Recruiting

College Park, Maryland, United States, 20742

Contacts

More Information

Sponsor

University of Maryland, College Park

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Maryland, College Park on 2025-12-23.