CompletedPhase 4

14-day Susceptibility-guided Bismuth Quadruple Therapy for Multiple Drug Resistant H. Pylori Infection

Taiwan46 participantsStarted 2022-08-22

Plain-language summary

The goal of this clinical trial is to learn if the 14-day susceptibility-guided bismuth quadruple therapy works to treat multiple drug resistant Helicobacter pylori (H. pylori) in adults. It will also learn about the adverse effects of bismuth quadruple therapy. The main questions it aims to answer are: * Does 14-day susceptibility-guided bismuth quadruple therapy higher the eradication rate? * What medical problems do participants have when taking 14-day susceptibility-guided bismuth quadruple? Researchers will record 14-day susceptibility-guided bismuth quadruple to see if 14-day susceptibility-guided bismuth quadruple works to treat multiple drug resistant H. pylori. Participants will: * Take susceptibility-guided bismuth quadruple every day for 14 days * Visit the clinic once 4-6 weeks for checkups and tests * Keep a diary of their symptoms during taking susceptibility-guided bismuth quadruple

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * H. pylori-infected with treatment experience with at least one course of eradication failure * H. pylori-infected with treatment naïve but having multiple-drug resistant H. pylori (\>= three antibiotics) * H. pylori infection confirmed by H. pylori culture Exclusion Criteria: * Previous allergic reactions to regimens, including amoxicillin, bismuth subcitrate, esomeprazole, metronidazole, rifabutin, and tetracycline, * Severe comorbidities, * Chronic kidney disease with estimated glomerular filtration rate \< 60 ml/min/1.73 m2, * Pregnant or breastfeeding women. * Dual-resistant H. pylori infection * Mono-resistant H. pylori infection * All susceptible H. pylori infection * Positive RUT but negative H. pylori culture * Negative RUT and negative H. pylori culture * Decline to participate

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The eradication rate of H. pylori

Timeframe: From enrollment to the end of treatment at 6-8 weeks

Trial details

NCT IDNCT06687499

SponsorNational Cheng-Kung University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Helicobacter Pylori trials