[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563022":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":52,"locations":58,"responsibleParty":131,"collaborators":26,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":26,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":26,"studyType":147,"phases":148,"briefSummary":150,"conditions":151,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Xijing Hospital of Digestive Diseases","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"The ursodeoxycholic acid group","EXPERIMENTAL","Patients in the ursodeoxycholic acid group will receive oral ursodeoxycholic acid at a dosage of 250 mg three times daily for 6 months.",[13],"Drug: Ursodeoxycholic Acid",{"label":15,"type":16,"description":17,"interventionNames":18},"The placebo group","PLACEBO_COMPARATOR","Patients in the placebo group will receive oral placebo at a dosage of 250 mg three times daily for 6 months.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ursodeoxycholic Acid","Subjects will be instructed to take one capsule (250mg) of ursodeoxycholic acid three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Subjects will be instructed to take one capsule (250mg) of placebo three times daily, and visit the hospital every 4 weeks for evaluation of the subjective symptoms and to receive a new supply of medication.",[15],[32,36,40,43,46,49],{"name":33,"affiliation":34,"role":35},"Yongquan Shi, PhD","Air Force Military Medical University, China","STUDY_CHAIR",{"name":37,"affiliation":38,"role":39},"Xinzhao Wang","989 Hospital of PLA Joint Logistics Support Force","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Kun Zhuang","Xi'an Central Hospital",{"name":44,"affiliation":45,"role":39},"Zhufang Ma","Hanzhong 3201 Hospital",{"name":47,"affiliation":48,"role":39},"Yuan Gao","Ankang Central Hospital",{"name":50,"affiliation":51,"role":39},"Long Zou","Shangluo Central Hospital",[53],{"name":54,"role":55,"phone":56,"phoneExt":26,"email":57},"Yongquan Shi","CONTACT","0086 + 02984771515","shiyquan@fmmu.edu.cn",[59,75,87,98,110,123],{"facility":38,"status":60,"city":61,"state":62,"zip":26,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Pingdingshan","Henan","China","CN",{"type":66,"coordinates":67},"Point",[68,69],113.31554,33.73091,{"lat":69,"lon":68},[72],{"name":37,"role":55,"phone":73,"phoneExt":26,"email":74},"0375-3843070","xinzhw66@163.com",{"facility":48,"status":60,"city":76,"state":77,"zip":26,"country":63,"countryCode":64,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Ankang","Shaanxi",{"type":66,"coordinates":79},[80,81],109.01722,32.68,{"lat":81,"lon":80},[84],{"name":47,"role":55,"phone":85,"phoneExt":26,"email":86},"0915-2391384","gaoyuan015@163.com",{"facility":45,"status":60,"city":88,"state":77,"zip":26,"country":63,"countryCode":64,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hanzhong",{"type":66,"coordinates":90},[91,92],107.02214,33.07507,{"lat":92,"lon":91},[95],{"name":44,"role":55,"phone":96,"phoneExt":26,"email":97},"0916-2380433","369852677@qq.com",{"facility":51,"status":60,"city":99,"state":77,"zip":26,"country":63,"countryCode":64,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Shangluo",{"type":66,"coordinates":101},[102,103],109.93056,33.86667,{"lat":103,"lon":102},[106],{"name":107,"role":55,"phone":108,"phoneExt":26,"email":109},"Ya Lan","0914-2360126","lylan2013@163.com",{"facility":111,"status":60,"city":112,"state":77,"zip":113,"country":63,"countryCode":64,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Xijing hospital","Xi'an","710032",{"type":66,"coordinates":115},[116,117],108.92861,34.25833,{"lat":117,"lon":116},[120],{"name":121,"role":55,"phone":122,"phoneExt":26,"email":57},"Yongquan Shi Shi","029-84771515",{"facility":42,"status":60,"city":112,"state":77,"zip":26,"country":63,"countryCode":64,"cosmosGeoPoint":124,"geoPoint":126,"contacts":127},{"type":66,"coordinates":125},[116,117],{"lat":117,"lon":116},[128],{"name":41,"role":55,"phone":129,"phoneExt":26,"email":130},"029-62812259","1033077816@qq.com",{"type":132,"investigatorFullName":54,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Professor","100563022","phase-4-efficacy-and-safety-of-ursodeoxycholic-acid-in-reversing-gastric-intestinal-metaplasia-100563022",false,"NCT06610760","Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia","Efficacy and Safety of Ursodeoxycholic Acid in Reversing Gastric Intestinal Metaplasia: A Multicenter, Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* patients aged from 18 to 75 years old.\n* patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.\n* patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.\n\nExclusion Criteria:\n\n* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and\u002For statins.\n* a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.\n* a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.\n* breastfeeding or pregnancy.\n* a history of substance abuse or alcohol abuse within the past one year.\n* patients with severe mental illness.\n* refusal to undergo drug treatment.\n* refusal to sign informed consent.","ALL","18 Years","75 Years",{"count":145,"type":146},196,"ESTIMATED","INTERVENTIONAL",[149],"PHASE4","The goal of this clinical trial is to investigate the efficacy of ursodeoxycholic acid in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of ursodeoxycholic acid. The main questions it aims to answer are:\n\nDoes ursodeoxycholic acid promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking ursodeoxycholic acid? Researchers will compare ursodeoxycholic acid to a placebo (a look-alike substance that contains no drug) to see if ursodeoxycholic acid is effective in treating gastric intestinal metaplasia.\n\nParticipants will:\n\nTake ursodeoxycholic acid or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.",[152],"Gastric Intestinal Metaplasia","2025-12-04",{"date":155,"type":156},"2025-12-05","ACTUAL",{"date":158,"type":156},"2024-11-12",{"date":160,"type":146},"2026-10-31",{"name":54,"class":6},6]