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Evaluation of the therapeutic effect of dual dose combination therapy (P-CAB+Amoxicillin) in the rescue treatment of Helicobacter pylori

Evaluation of the therapeutic effect of dual dose combination therapy (P-CAB+Amoxicillin) in the rescue treatment of Helicobacter pylori

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101213
Enrollment
Unknown
Registered
2025-04-22
Start date
2024-05-02
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Helicobacter pylori infection

Interventions

Group A:Take "Vonoprazan 20mg bid + Amoxicillin 1g tid" for 14 days.
Group B:Classic quadruple therapy (empirical replacement of antibiotics).
Group C:Collect stool specimens for PCR drug resistance gene testing, and provide individualized quadruple therapy based on the results of the drug resistance test.

Sponsors

Northern Jiangsu People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as Hp positive through 13C-urea breath test who have previously failed to eradicate Hp; 2. More than 6 months since the last eradication of Hp; 3. Understand and be willing to participate in this clinical trial and sign an informed consent form; 4. Age range from 18 to 75 years old (including 18 and 75 years old), regardless of gender; 5. During the period from the time when the subject agreed to be included in the study to the end of the study (that is, the end of the efficacy evaluation visit), it is prohibited to take any antibiotics other than the test drugs or traditional Chinese patent medicines and simple preparations, bismuth agents, acid inhibitors (such as PPI, H2 receptor blockers, P-CAB, etc.) with antibacterial effects.

Exclusion criteria

Exclusion criteria: 1.Individuals with contraindications to penicillin or research protocol related drug allergies; 2.History of gastrectomy; 3.History of gastric malignant tumors, including adenocarcinoma and lymphoma; 4.A history of gastrointestinal diseases with difficulty swallowing or any impact on drug absorption; 5.Individuals with a history of severe central nervous system, cardiovascular, pulmonary, liver, kidney, metabolic, gastrointestinal, urinary, endocrine, and hematological diseases or a history of malignant tumors; 6.Individuals with severe mental illness who cannot cooperate or have communication difficulties; 7.Pregnant, lactating or preparing women; 8.Individuals who have taken bismuth, acid inhibitors, antibiotics, or traditional Chinese medicine with bactericidal effects within the past 4 weeks; 9.Merge other bacterial and viral infections in the past 2 weeks; 10.Participating in other clinical trials; 11.Researchers believe that participants are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
The eradication rate of Helicobacter pylori;

Secondary

MeasureTime frame
The rate of adverse reaction incidence;Economic cost;

Countries

China

Contacts

Public ContactLei Chen

Northern Jiangsu People's Hospital

18051060569@yzu.edu.cn+86 180 5106 0569

Outcome results

None listed

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