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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-22

Study Completion Date

2024-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Susceptibility-guided Bismuth Quadruple Therapy for Multiple-resistant Helicobacter Pylori Strains

NCT06687473

Helicobacter Pylori Drug Resistance, Multiple Virulence Factor

COMPLETED PHASE4

Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic

NCT05577572

H.Pylori Gastrointestinal Disease

UNKNOWN NA

Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)

NCT05997433

Helicobacter Pylori Infection

RECRUITING NA

Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies

NCT03779074

Helicobacter Pylori Infection

COMPLETED PHASE3

The Efficacy of 10-day or 14-day Course of Bismuth-containing Quadruple Therapy:A Randomized Clinical Trial

NCT05586113

Helicobacter Pylori Infection

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Helicobacter pylori (H. pylori) infection is the major culprit of dyspeptic symptoms, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma.

The antibiotic resistance of H. pylori infection is an emerging issue. Moreover, amoxicillin-resistant H. pylori strains increased recently. The amoxicillin resistance rates were 9% in Asia and up to 39% in South America.

Susceptibility-guided therapy is superior to empiric therapy in 2nd-line therapy. After twice eradication failure, H. pylori culture for susceptibility test is strongly recommended, which guide clinician to choose appropriate susceptibility-based therapy. The multiple drug resistant rates may be higher in patients who fail two or more eradication therapy; thus, susceptibility-guided therapy is currently the consensus recommendation for 3rd-line H. pylori eradication. Bismuth quadruple therapy could overcome either clarithromycin or metronidazole resistant strains. Several evidences of clinical randomized-controlled trials demonstrated that adding bismuth as the first line therapeutic regimen can capture additional 30%-40% successful eradication rate for the resistant strain, further contributing to the overall eradication rate.

Accordingly, the aim of our study was to validate the susceptibility-guided bismuth quadruple therapy in patients with multiple drug resistant H. pylori infection in terms of efficacy and side effects.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Helicobacter Pylori Drug Resistance, Multiple

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bismuth-based susceptibility-guided treatment

Participants who have triple- or quadruple-drug resistant H. pylori infection are enrolled. Participants receive one of the four regimens based on susceptibility test.

Group Type EXPERIMENTAL

Bismuth-based susceptibility-guided treatment

Intervention Type DRUG

The investigators design four regimes for H. pylori eradication and participants receive one of the regimens based on susceptibility test. The four regimens are PBAT for those with both amoxicillin and tetracycline susceptible H. pylori; PBAM for those with amoxicillin susceptible but tetracycline resistant H. pylori; PBMT for those with amoxicillin resistant but tetracycline susceptible H. pylori; PBMR for those with both amoxicillin and tetracycline resistant H. pylori. A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e., esomeprazole (40 mg twice daily), R is rifabutin (150 mg twice daily), and T is tetracycline (500 mg thrice daily). The treatment duration is 14 days for all regimens.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bismuth-based susceptibility-guided treatment

The investigators design four regimes for H. pylori eradication and participants receive one of the regimens based on susceptibility test. The four regimens are PBAT for those with both amoxicillin and tetracycline susceptible H. pylori; PBAM for those with amoxicillin susceptible but tetracycline resistant H. pylori; PBMT for those with amoxicillin resistant but tetracycline susceptible H. pylori; PBMR for those with both amoxicillin and tetracycline resistant H. pylori. A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e., esomeprazole (40 mg twice daily), R is rifabutin (150 mg twice daily), and T is tetracycline (500 mg thrice daily). The treatment duration is 14 days for all regimens.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No