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Fecal Molecular Susceptibility-guided Hp Rescue Therapy

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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
Trial Details
NCT Number NCT07405697
Lead Sponsor Shanghai Zhongshan Hospital
Conditions
(from sponsor)		 Helicobacter Pylori Infection
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov