[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624134":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":77,"collaborators":11,"id":79,"slug":11,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":11,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":11,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":99,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"7-day","EXPERIMENTAL",null,[13],"Drug: 7-day fecal molecular susceptibility-guided therapy",{"label":15,"type":16,"description":11,"interventionNames":17},"14-day","ACTIVE_COMPARATOR",[18],"Drug: 14-day fecal molecular susceptibility-guided therapy",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","7-day fecal molecular susceptibility-guided therapy","This intervention involves performing polymerase chain reaction (PCR)-based detection of Helicobacter pylori drug resistance genes (including clarithromycin, levofloxacin) from fecal samples. Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"14-day fecal molecular susceptibility-guided therapy","This intervention involves performing polymerase chain reaction (PCR)-based detection of Helicobacter pylori drug resistance genes (including clarithromycin, levofloxacin) from fecal samples. Based on the susceptibility results, a tailored 14-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Qi Chen","CONTACT","86-17811921405","chenqimd@163.com",[36,48,59,68],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":11},"Renji Hospital, School of Medicine, Shanghai Jiaotong University","Shanghai","Shanghai Municipality","200000","China",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},{"facility":49,"status":11,"city":38,"state":39,"zip":11,"country":41,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"Shanghai Jiangong Hospitail.",{"type":43,"coordinates":51},[45,46],{"lat":46,"lon":45},[54,56],{"name":55,"role":32,"phone":11,"phoneExt":11,"email":11},"Qi Liao, MD",{"name":57,"role":58,"phone":11,"phoneExt":11,"email":11},"Qi Liao","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":11,"city":38,"state":39,"zip":11,"country":41,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Shanghai Tenth People Hospital",{"type":43,"coordinates":62},[45,46],{"lat":46,"lon":45},[65,67],{"name":66,"role":32,"phone":11,"phoneExt":11,"email":11},"Yan Zhao, MD",{"name":66,"role":58,"phone":11,"phoneExt":11,"email":11},{"facility":69,"status":11,"city":38,"state":11,"zip":11,"country":41,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Zhongshan Hospital, Fudan University",{"type":43,"coordinates":71},[45,46],{"lat":46,"lon":45},[74,75],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":76,"role":58,"phone":11,"phoneExt":11,"email":11},"Hong Gao, MD",{"type":78,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624134",false,"NCT07405684","Fecal Molecular Susceptibility-guided Hp First-line Therapy","Clinical Efficacy and Health Economic Evaluation of Fecal Molecular Susceptibility-guided Therapy for Helicobacter Pylori Infection First-line Treatment: Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n1. Voluntarily participate in this clinical study; fully understand, be informed about this study, and sign the Informed Consent Form (ICF).\n2. Age between 18 and 75 years (inclusive) on the day of signing the ICF.\n3. 13C-urea breath test (13C-UBT) and fecal HP nucleic acid detection confirming Helicobacter pylori (Hp) infection.\n4. Not previously eradicated HP\n\nExclusion Criteria:\n\n1. Individuals with a known allergy to the medication.\n2. Patients with severe cardiovascular, pulmonary, renal, hepatic, hematologic, neurologic, endocrine, or psychiatric disorders;\n3. Participants or guardians who refuse to enroll;\n4. Alcohol and\u002For drug abuse (dependence or addiction) or individuals judged by the physician to have poor compliance; 5) Use of antibiotics, bismuth-containing drugs, PPIs, or traditional Chinese medicines within 4 weeks before treatment; 6) Pregnant or lactating women; 7) Any condition deemed by the investigator to be unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":89,"type":90},544,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","The goal of this clinical trial is to evaluate the eradication efficacy and health economic benefits of individualized regimens guided by fecal molecular susceptibility testing with 7-day and 14-day courses in the first-line treatment of Helicobacter pylori infection. The main questions it aims to answer are:\n\n1. What is the H. pylori eradication rate of the 7-day versus 14-day individualized regimens?\n2. What are the safety, adherence, and cost-effectiveness of the 7-day versus 14-day individualized regimens? Researchers will compare the 7-day course group and the 14-day course group to see if the 7-day course is non-inferior to the 14-day course in terms of eradication rate.\n\nParticipants will:\n\n1. Undergo fecal H. pylori drug resistance gene testing\n2. Receive randomized assignment to either 7-day or 14-day individualized treatment based on drug susceptibility results\n3. Complete follow-up visits at 1 week and 4-8 weeks after stopping treatment for adverse event monitoring and 13C-urea breath test",[96],"HELICOBACTER PYLORI INFECTIONS",[98],"Helicobacter pylori","NOT_YET_RECRUITING","2026-02-10",{"date":102,"type":103},"2026-02-12","ACTUAL",{"date":105,"type":90},"2026-02-28",{"date":107,"type":90},"2028-12-31",{"name":5,"class":6},4]