All Health Backgrounds to Determine a Baseline of Flatus ActivityNCT07134543
Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
An observational study of All Health Backgrounds to Determine a Baseline of Flatus Activity, run by University of Maryland, College Park at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- All Health Backgrounds to Determine a Baseline of Flatus Activity
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the US
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Bioscience Research Building
College Park, Maryland, 20742
Brantley Hall, PhD, 540-797-8040, brantley@umd.edu
- Recruiting
University of Maryland Bioscience Research Building
College Park, Maryland, 20742
Branley Hall, PhD, 301-405-7481, brantley@umd.edu
About this study
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:
Read more
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours each day for 3 days
Secondary outcomes (4)
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.
Measured: 12 hours each day for 3 days
Flatus Per Hour
The rate of flatus events normalized per hour, calculated from the total number of events and the total monitored time.
Measured: 12 hours each day for 3 days
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.
Measured: 12 hours each day for 3 days
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.
Measured: 12 hours each day for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Dec 2025
- Primary completion5 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Health Backgrounds to Determine a Baseline of Flatus ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134543
- Sponsor's protocol ID
- Human Flatus Atlas
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified, aggregate individual participant data limited to total enrollment numbers and demographic characteristics (e.g., age range, sex distribution, and other baseline variables) collected during the study. No other data, including outcome or clinical data, will be shared. Supporting Information The shared dataset will not contain any information that could directly or indirectly identify participants. Data will be available in aggregate format only, and will be provided upon reasonable request from qualified researchers for the purposes of scientific transparency and verification of study population characteristics.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
- ClinicalTrials.gov ID
- NCT07134543
- Acronym / sponsor ID
- Human Flatus Atlas
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the US
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbiome Activity Index
Time frame: 12 hours each day for 3 days
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. We plan to share de-identified, aggregate individual participant data limited to total enrollment numbers and demographic characteristics (e.g., age range, sex distribution, and other baseline variables) collected during the study. No other data, including outcome or clinical data, will be shared. Supporting Information The shared dataset will not contain any information that could directly or indirectly identify participants. Data will be available in aggregate format only, and will be provided upon reasonable request from qualified researchers for the purposes of scientific transparency and verification of study population characteristics.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Health Backgrounds to Determine a Baseline of Flatus Activity, run by University of Maryland, College Park at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brantley Hall, PhD (5407978040, brantley@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome Activity Index (time frame: 12 hours each day for 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.