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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

4 sites across 1 country: China