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Fecal Molecular Susceptibility-guided Hp Rescue Therapy
Sponsor: Shanghai Zhongshan Hospital
Summary
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: 1. What is the H. pylori eradication rate of the 7-day versus 14-day individualized regimens? 2. 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. Participants will: 1. Undergo fecal H. pylori drug resistance gene testing 2. Receive randomized assignment to either 7-day or 14-day individualized treatment based on drug susceptibility results 3. Complete follow-up visits at 1 week and 4-8 weeks after stopping treatment for adverse event monitoring and 13C-urea breath test
Official title: Clinical Efficacy and Health Economic Evaluation of Fecal Molecular Susceptibility-guided Therapy for Helicobacter Pylori Infection Rescue Treatment: Multicenter Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2026-02-28
Completion Date
2028-12-31
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
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.
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 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.
Locations (4)
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Shanghai Jiangong Hospitail.
Shanghai, Shanghai Municipality, China
Shanghai Tenth People Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, China