[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603286":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":30,"armGroups":31,"interventions":26,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":69,"collaborators":26,"id":71,"slug":26,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":26,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":26,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":26,"briefSummary":83,"conditions":84,"keywords":26,"overallStatus":61,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Maryland, College Park","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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.","12 hours each day for 3 days",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"Flatus Per Hour","The rate of flatus events normalized per hour, calculated from the total number of events and the total monitored time.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"Fiber-Normalized Flatus Frequency","The participant's flatus frequency (events\u002Fday) normalized by self-reported dietary fiber intake (grams\u002Fday). Normalization will allow assessment of typical adult flatulence frequency in relation to fiber consumption.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"ECOLOGIC_OR_COMMUNITY","PROSPECTIVE","Residents of the US",[32],{"label":33,"type":26,"description":34,"interventionNames":26},"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.",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Brantley Hall, PhD","CONTACT","5407978040","brantley@umd.edu",[42,59],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Bioscience Research Building","NOT_YET_RECRUITING","College Park","Maryland","20742","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-76.93692,38.98067,{"lat":54,"lon":53},[57],{"name":37,"role":38,"phone":58,"phoneExt":26,"email":40},"540-797-8040",{"facility":60,"status":61,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"University of Maryland Bioscience Research Building","RECRUITING",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":67,"role":38,"phone":68,"phoneExt":26,"email":40},"Branley Hall, PhD","301-405-7481",{"type":70,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100603286",false,"NCT07134543","Using the Smart Underwear Device to Determine a Baseline of Flatus Activity Normalized to Fiber Intake","Inclusion Criteria:\n\n* 18 years old or older\n* Lives in the US\n* Is not pregnant or lactating\n* Is willing to wear the Smart Underwear device as instructed in the study procedures\n\nExclusion Criteria:\n\n* Younger than 18 years old\n* Lives outside the US\n* Is pregnant or lactating\n* Is not willing to wear the Smart Underwear device as instructed in the study procedures",true,"ALL","18 Years",{"count":80,"type":81},500,"ESTIMATED","OBSERVATIONAL","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.\n\nThe main questions it aims to answer are:\n\n* What is the average frequency of flatus events in a general adult population?\n* How does dietary fiber intake influence flatus frequency and microbiome activity?\n\nResearchers 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.\n\nParticipants will:\n\n* Complete an online eligibility survey, consent form, and background questionnaire.\n* Wear the Smart Underwear device for at least 12 hours per day for three consecutive days.\n* Log all meals with photos using a custom smartphone app.\n* Complete a short post-wear survey about device comfort and usability.\n\nAll 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.",[85],"All Health Backgrounds to Determine a Baseline of Flatus Activity","2025-12-19",{"date":88,"type":89},"2025-12-23","ACTUAL",{"date":91,"type":89},"2025-12-01",{"date":93,"type":81},"2026-12-01",{"name":5,"class":6},2]