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Efficacy and Safety of Keverprazan-Amoxicillin Dual Therapy Versus Bismuth-Containing Quadruple Therapy as Rescue Treatment for Helicobacter Pylori Infection: A Prospective Multicenter Randomized Controlled Trial

Efficacy and Safety of Keverprazan-Amoxicillin Dual Therapy Versus Bismuth-Containing Quadruple Therapy as Rescue Treatment for Helicobacter Pylori Infection: A Prospective Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116788
Enrollment
Unknown
Registered
2026-01-15
Start date
2026-01-22
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori

Interventions

bismuth quadruple therapy group:Esomeprazole+Amoxicillin+Furazolidone+Colloidal Bismuth Pectin

Sponsors

Northern Jiangsu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18–70 years, regardless of gender; 2. A history of at least one failed course of H. pylori eradication therapy; 3. Confirmed H. pylori infection, as diagnosed by a positive result in any one of the following tests: ¹³C/¹4C-urea breath test, rapid urease test, stool antigen test, histology, or bacterial culture; 4. Provision of informed consent and voluntary participation in the study.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic to the study medication; 2. Those who have used antibiotics, bismuth preparations, and probiotics in the past 4 weeks or potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), or H2-receptor antagonists in the past 2 weeks; 3. Previous receipt of the identical treatment regimen used in either the experimental group or the control group; 4. Current pregnancy, lactation, or pregnancy planning; 5. Complicated by severe diseases of the heart, liver, lungs, kidneys, or other vital organs, or concomitant diagnosis of gastrointestinal malignancy; 6. Inability to cooperate with the study due to alcoholism, substance abuse, severe mental illness, or other relevant conditions..

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate ;

Secondary

MeasureTime frame
Adverse events;Compliance;

Countries

China

Contacts

Public ContactBen-Gang Zhou

Northern Jiangsu People's Hospital

zhoubengang198903@126.com+86 180 5106 9350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026