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Rescue Therapy for Helicobacter Pylori Infection

NCT05874544 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-09-15

No results posted yet for this study

Summary

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Vonoprazan

Proton pump inhibitor

DRUG

Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

DRUG

Tetracycline

Antibiotics for H. pylori eradication

DRUG

Metronidazole

Antibiotics for H. pylori eradication

DRUG

Amoxicillin

Antibiotics for H. pylori eradication

DRUG

Rifabutin

Antibiotics for H. pylori eradication

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874544 on ClinicalTrials.gov