[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624134":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":78,"collaborators":11,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":11,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":11,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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",[36,49,60,69],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Renji Hospital, School of Medicine, Shanghai Jiaotong University","Shanghai","Shanghai Municipality","200000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},{"facility":50,"status":11,"city":38,"state":39,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"Shanghai Jiangong Hospitail.",{"type":44,"coordinates":52},[46,47],{"lat":47,"lon":46},[55,57],{"name":56,"role":32,"phone":11,"phoneExt":11,"email":11},"Qi Liao, MD",{"name":58,"role":59,"phone":11,"phoneExt":11,"email":11},"Qi Liao","PRINCIPAL_INVESTIGATOR",{"facility":61,"status":11,"city":38,"state":39,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Shanghai Tenth People Hospital",{"type":44,"coordinates":63},[46,47],{"lat":47,"lon":46},[66,68],{"name":67,"role":32,"phone":11,"phoneExt":11,"email":11},"Yan Zhao, MD",{"name":67,"role":59,"phone":11,"phoneExt":11,"email":11},{"facility":70,"status":11,"city":38,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"Zhongshan Hospital, Fudan University",{"type":44,"coordinates":72},[46,47],{"lat":47,"lon":46},[75,76],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"name":77,"role":59,"phone":11,"phoneExt":11,"email":11},"Hong Gao, MD",{"type":79,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100624134","phase-4-fecal-molecular-susceptibility-guided-hp-first-line-therapy-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":91,"type":92},544,"ESTIMATED","INTERVENTIONAL",[95],"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",[98],"HELICOBACTER PYLORI INFECTIONS",[100],"Helicobacter pylori","NOT_YET_RECRUITING","2026-02-10",{"date":104,"type":105},"2026-02-12","ACTUAL",{"date":107,"type":92},"2026-02-28",{"date":109,"type":92},"2028-12-31",{"name":5,"class":6},4]