Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

NCT06731023 · tracked via the Priya Life Science China tracker

Sponsor

Xiuli Zuo

Phase

Observational

Started

2025-01-01

Last updated

2024-12-19

Condition(s) studied

HELICOBACTER PYLORI INFECTIONS

Investigational drug(s) / intervention(s)

BismuthVonoprazanAmoxicillinRifabutinMetronidazoleOther antibiotics

Bismuth: Bismuth 0.6g bid

Vonoprazan: vonoprazan 20mg bid

Amoxicillin: Amoxicillin 1g bid

Rifabutin: Rifabutin 0.15g bid

Metronidazole: Metronidazole 400mg qid

Other antibiotics: The selection of other antibiotics is based on the results of drug susceptibility testing.

Study summary

Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Patients aged 18-65. 2. Patients with H.pylori infection (Positive for rapid urease test or 13C urea breath test). 3. Received at least two previous standard treatment protocols for Helicobacter pylori, and the application regimens included at least three low-resistance antibiotics. Exclusion Criteria: 1. Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%. 2. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial. 3. Patients with active gastrointestinal bleeding. 4. Patients with a history of upper gastrointestinal surgery. 5. Patients allergic to treatment drugs. 6. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks 7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse 8. Patients who are unwilling or incapable to provide informed consents.

Primary outcome measure(s)

Eradication rate — Immediately after follow-up check.

Trial sites (1)

Facility	City	Region	Status
Qilu Hospital of Shandong University	Jinan	Shandong

On this site

📄 Amoxil (amoxicillin) drug profile →

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Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota. Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06731023 on ClinicalTrials.gov ↗ ← All trials in China