Fecal Molecular Susceptibility-guided Hp Rescue Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Eradication rate of Helicobacter pylori — 4-8 weeks after treatment
  Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value)

Trial sites (4)

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