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NCT07134543 · ClinicalTrials.gov registry record
Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake
A clinical trial of All Health Backgrounds to Determine a Baseline of Flatus Activity, sponsored by University of Maryland, College Park.
- Recruiting
- Registry status
- 500
- Enrollment target
- 2
- Study locations
NCT07134543: Recruiting study of All Health Backgrounds to Determine a Baseline of Flatus Activity, sponsored by University of Maryland, College Park.
NCT07134543 is a study of All Health Backgrounds to Determine a Baseline of Flatus Activity that is actively recruiting participants, run by University of Maryland, College Park. The registered enrollment target is 500 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07134543, a study of All Health Backgrounds to Determine a Baseline of Flatus Activity, is actively recruiting participants, sponsored by University of Maryland, College Park.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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 concent
Conditions Studied
Study Locations (2)
Maryland
- Bioscience Research Building - College Park
- University of Maryland Bioscience Research Building - College Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-12-01 |
| Est. Completion | 2026-12-01 |
What NCT07134543 shows while recruiting
NCT07134543 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with All Health Backgrounds to Determine a Baseline of Flatus Activity appearing as the primary indexed condition, and to 0 interventions.
NCT07134543 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07134543 about?
NCT07134543 is a clinical study titled "Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake". 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 co...
What is the current status of trial NCT07134543?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2025-12-01. Estimated completion is 2026-12-01.
What conditions does trial NCT07134543 study?
This clinical trial studies the following conditions: All Health Backgrounds to Determine a Baseline of Flatus Activity.
Who is sponsoring clinical trial NCT07134543?
This trial is sponsored by University of Maryland, College Park, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07134543 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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