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NOT YET RECRUITING
NCT06731023

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

Sponsor: Xiuli Zuo

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-01-01

Completion Date

2026-12-31

Last Updated

2024-12-19

Healthy Volunteers

No

Interventions

DRUG

Bismuth

Bismuth 0.6g bid

DRUG

Vonoprazan

vonoprazan 20mg bid

DRUG

Amoxicillin

Amoxicillin 1g bid

DRUG

Rifabutin

Rifabutin 0.15g bid

DRUG

Metronidazole

Metronidazole 400mg qid

DRUG

Other antibiotics

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

Locations (1)

Qilu Hospital of Shandong University

Jinan, Shandong, China