[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100350376":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Individuals","ACTIVE_COMPARATOR","Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry",[13,14],"Diagnostic Test: Rectal Barostat Study","Diagnostic Test: Fecoflowmetry",{"label":16,"type":10,"description":17,"interventionNames":18},"Constipated Individuals","60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Rectal Barostat Study","Contractions will be recorded with a balloon inserted into the rectum and inflated",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Fecoflowmetry","Rectum will be filled with a small amount of paste.Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.",[16,9],[31],{"name":32,"affiliation":5,"role":33},"Adil E Bharucha, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Kelly J Feuerhak","CONTACT","507-255-6802","Feuerhak.Kelly@mayo.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-92.4699,44.02163,{"lat":53,"lon":52},[56,57],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Adil Bharucha, MBBS, MD","Principal Investigator",[62],{"name":63,"class":64},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100350376","understanding-mechanisms-of-normal-and-disordered-defecation-100350376",false,"NCT03842007","Understanding Mechanisms of Normal and Disordered Defecation","Inclusion Criteria\n\n* Male and female volunteers aged 18-80 years.\n* Able to provide written informed consent before participating in the study.\n* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.\n* Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: \\\u003C3 bowel motions\u002Fweek, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, anal digitation ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.\n* Able to provide written informed consent before participating in the study.\n* Able to communicate adequately with the investigator and to comply with the requirements for the entire study.\n\nExclusion Criteria\n\n* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and\u002For pose safety concerns.\n* Current symptoms of a functional gastrointestinal disorder assessed by questionnaire.\n* Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight \\>4500gms (macrosomia), or known 3rd or 4th degree perineal tear.\n* Medications that are likely to alter gastrointestinal motility: e.g., opiates and anticholinergic medications; a stable dose of thyroxine and low doses of tricyclic agents (e.g., up to amitriptyline (50 mg daily).\n* Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.\\*\n* Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire.\n* Pregnant women, prisoners and institutionalized individuals.",true,"ALL","18 Years","80 Years",{"count":76,"type":77},160,"ESTIMATED","INTERVENTIONAL",[80],"NA","Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.",[83],"Constipation","2026-08-19",{"date":86,"type":87},"2026-08-21","ACTUAL",{"date":89,"type":87},"2019-01-29",{"date":91,"type":77},"2029-06",{"name":5,"class":6},1]