Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: All Health Backgrounds to Determine a Baseline of Flatus Activity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Microbiome Activity Index [Time frame: 12 hours each day for 3 days]
Secondary outcome measures (4)
- Total flatus count [Time frame: 12 hours each day for 3 days]
- Flatus Per Hour [Time frame: 12 hours each day for 3 days]
- Microbiome Activity Index Comparative Score [Time frame: 12 hours each day for 3 days]
- Fiber-Normalized Flatus Frequency [Time frame: 12 hours each day for 3 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Ecologic or community
Study locations
United States · 2 centers
- Bioscience Research Building — College Park
- University of Maryland Bioscience Research Building — College Park
Identifiers
NCT: NCT07134543 · Human Flatus Atlas