[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453520":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":35,"centralContacts":40,"locations":46,"responsibleParty":63,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":10,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":49,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Region Örebro County","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy volunteers",null,"Healthy volunteers aged 18-to 65",[13,14],"Other: Exposure 1: Visceral hypersensitivity or phenotype suggestive of IBS","Other: Exposure 2: Changes in anorectal motor function or compliance.",{"label":16,"type":10,"description":17,"interventionNames":18},"Asymptomatic patients with quiescent IBD","Asymptomatic patients with IBD in remission.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Symptomatic patients with quiescent UC","Symptomatic patients with UC in remission",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Symptomatic patients with quiescent CD with anorectal involvement","Symptomatic patients with CD with distal involvement of the colon or perianal disease",[13,14],[28,32],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Exposure 1: Visceral hypersensitivity or phenotype suggestive of IBS","Assess the relation between the exposure and the outcome which is persistent symptoms in the patients with quiescent disease.",[16,9,24,20],{"type":6,"name":33,"description":30,"armGroupLabels":34,"otherNames":10},"Exposure 2: Changes in anorectal motor function or compliance.",[16,9,24,20],[36],{"name":37,"affiliation":38,"role":39},"Michiel van Nieuwenhoven, assoc prof","University Hospital Örebro","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":45},"Lucian Marinica Grando, phd student","CONTACT","0046196021794","lucian.marinica-grando@regionorebrolan.se",[47],{"facility":48,"status":49,"city":50,"state":10,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University hospital Örebro","RECRUITING","Örebro","70185","Sweden","SE",{"type":55,"coordinates":56},"Point",[57,58],15.2066,59.27412,{"lat":58,"lon":57},[61],{"name":42,"role":43,"phone":44,"phoneExt":10,"email":62},"lucian.marinica-grando@reionorebrolan.se",{"type":64,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100453520","assessment-of-anorectal-function-in-patients-with-inflammatory-bowel-disease-100453520",false,"NCT05185609","Assessment of Anorectal Function in Patients With Inflammatory Bowel Disease","Assessment of Anorectal Function in Healthy Volunteers and Patients With Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Healthy volunteers\n* Symptomatic IBD patients: Moderate to severe IBD in remission with persistent symptoms as reported by symptom index and short health scale.\n* Asymptomatic IBD patients: moderate to severe IBD in remission without symptoms\n\nExclusion Criteria:\n\nHealthy volunteers:\n\n* gastrointestinal disease, functional gastrointestinal symptoms,\n* psychiatric disease\n* anal or pelvic surgery, inclusive interventions during delivery\n* diabetes, cardiovascular, renal, or hepatic disease,\n* concurrent or recent treatment with drugs affecting intestinal function or mood (antidepressants), nutritional supplements or herb products affecting intestinal function (probiotics), abuse of alcohol or drugs, and a recent (\\\u003C 2 weeks) history of systemic steroid therapy.\n\nIBD patients\n\n* active disease\n* anal or pelvic surgery, inclusive interventions during delivery\n* diabetes, cardiovascular, renal, or hepatic disease,\n* concurrent or recent treatment with drugs affecting intestinal function or mood (antidepressants), nutritional supplements or herb products affecting intestinal function (probiotics), abuse of alcohol or drugs, and a recent (\\\u003C 2 weeks) history of systemic steroid therapy. Patients taking antidiarrhoeal or laxatives can be included after a 48 h washout period.",true,"ALL","18 Years","65 Years",{"count":77,"type":78},70,"ESTIMATED","OBSERVATIONAL","Active inflammatory bowel disease (IBD) causes disabling symptoms such as diarrhea, involuntary loss of bowel control, abdominal pain and urges to pass stool. However, even patients with inactive IBD frequently experience such symptoms. The cause is not well understood and the functionality of the bowel in IBD patients is underexplored.\n\nEarlier studies show a wide range of results, but most find that patients with IBD in remission are up to four times as likely to report gastrointestinal symptoms when compared to healthy controls.\n\nChronic inflammation may cause changes of the bowel wall, like increased collagen deposits (fibrosis) and thus cause symptoms, but the absence of active inflammation in combination with presence of symptoms may also be regarded as resembling the clinical condition of irritable bowel syndrome (IBS).\n\nIBS is characterized by abdominal pain and changes in stool frequency and consistence and is often associated with disorders like depression and anxiety. Up to a third of IBD patients without signs of disease activity meet the criteria for IBS (irritable bowel syndrome. It can be speculated that an IBD diagnosis is a distressing event that can induce mood disorders, and an IBS-like condition.\n\nCharacterization of IBS patients relies on the Rome IV symptom criteria, symptom severity scales and measurements of rectal sensibility and rectal compliance using a barostat procedure.\n\nMotor function assessment relies on anorectal manometry which detects abnormalities of muscle function and coordination. Recently, a standardized high-resolution anorectal manometry protocol (HRAM) was published which also evaluates sensitivity and compliance. The level of agreement between the barostat method and the HRAM testing procedure regarding sensibility and rectal compliance is largely unknown.\n\nRecent studies have associated gut microorganisms, genetic factors, and proteins with various aspects of IBD. There is evidence that these potential markers may reflect non-inflammatory processes such as fibrosis.\n\nThe aim of this study is to explore the anorectal function in symptomatic patients with inactive IBD compared to healthy volunteers and asymptomatic patients, evaluate symptom severity and psychological parameters and perform molecular characterization.\n\nThe level of agreement of rectal sensitivity and compliance measurements with the barostat method and HRAM protocol will also be evaluated.",[82,83],"Inflammatory Bowel Diseases","Irritable Bowel Syndrome",[85,86,87],"Anorectal function","Anorectal manometry","Rectal barostat","2022-01-19",{"date":90,"type":91},"2022-02-03","ACTUAL",{"date":93,"type":91},"2021-09-01",{"date":95,"type":78},"2027-12-30",{"name":5,"class":6},1]