Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Maryland, College Park
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Residents of the US
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: American adults
Trial outcomes
Primary outcomes
1
Microbiome Activity Index
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.
Time frame
12 hours each day for 3 daysSecondary outcomes
1
Total flatus count
The total number of flatus events detected by the wearable device. Detection is based on hydrogen gas concentration changes and signal rate-of-change analysis.
Time frame
12 hours each day for 3 days2
Flatus Per Hour
The rate of flatus events normalized per hour, calculated from the total number of events and the total monitored time.
Time frame
12 hours each day for 3 days3
Microbiome Activity Index Comparative Score
A relative score comparing the participant's Microbiome Activity Index to aggregated anonymized results from other individuals in the Human Flatus Atlas study. Presented as a percentile rank or standardized score.
Time frame
12 hours each day for 3 days4
Fiber-Normalized Flatus Frequency
The participant's flatus frequency (events/day) normalized by self-reported dietary fiber intake (grams/day). Normalization will allow assessment of typical adult flatulence frequency in relation to fiber consumption.
Time frame
12 hours each day for 3 daysSponsors and contacts
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Source ClinicalTrials.gov