[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624135":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":69,"collaborators":25,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":92,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"7-day","EXPERIMENTAL","7-day fecal molecular susceptibility-guided therapy",[13],"Drug: 7-day fecal molecular susceptibility-guided therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"14-day","ACTIVE_COMPARATOR","14-day fecal molecular susceptibility-guided therapy",[19],"Drug: 14-day fecal molecular susceptibility-guided therapy",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","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],null,{"type":22,"name":17,"description":27,"armGroupLabels":28,"otherNames":25},"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 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,"affiliation":32,"role":33},"Hong Gao, MD","Fudan University","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Qi Chen, MD","CONTACT","86-17811921405","chenqimd@163.com",[41,54,59,64],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"Renji Hospital, School of Medicine, Shanghai Jiaotong University","Shanghai","Shanghai Municipality","200000","China","CN",{"type":49,"coordinates":50},"Point",[51,52],121.45806,31.22222,{"lat":52,"lon":51},{"facility":55,"status":25,"city":43,"state":44,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":56,"geoPoint":58,"contacts":25},"Shanghai Jiangong Hospitail.",{"type":49,"coordinates":57},[51,52],{"lat":52,"lon":51},{"facility":60,"status":25,"city":43,"state":44,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":25},"Shanghai Tenth People Hospital",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},{"facility":65,"status":25,"city":43,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":68,"contacts":25},"Zhongshan Hospital, Fudan University",{"type":49,"coordinates":67},[51,52],{"lat":52,"lon":51},{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624135","phase-4-fecal-molecular-susceptibility-guided-hp-rescue-therapy-100624135",false,"NCT07405697","Fecal Molecular Susceptibility-guided Hp Rescue Therapy","Clinical Efficacy and Health Economic Evaluation of Fecal Molecular Susceptibility-guided Therapy for Helicobacter Pylori Infection Rescue 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. 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;\n5. Use of antibiotics, bismuth-containing drugs, PPIs, or traditional Chinese medicines within 4 weeks before treatment;\n6. Pregnant or lactating women;\n7. Any condition deemed by the investigator to be unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":82,"type":83},290,"ESTIMATED","INTERVENTIONAL",[86],"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 rescue 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",[89],"Helicobacter Pylori Infection",[91],"Helicobacter pylori","NOT_YET_RECRUITING","2026-02-10",{"date":95,"type":96},"2026-02-12","ACTUAL",{"date":98,"type":83},"2026-02-28",{"date":100,"type":83},"2028-12-31",{"name":5,"class":6},4]