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Different dose Amoxicillin -PCAB Dual Therapy for Helicobacter pylori Eradication In the elderly population: A Prospective, Randomized, Multicenter Study in Fujian, China

Prospective Multicenter Randomized Controlled Clinical Study on the Efficacy and Safety of Different Dosage Regimens of Amoxicillin-PCAB Dual Therapy for Helicobacter pylori Eradication in Elderly Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104790
Enrollment
Unknown
Registered
2025-06-23
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-30

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: Amoxicillin (1000 mg per dose, twice daily) + Vonoprazan (20 mg per dose, once daily):Group A: Amoxicillin (1000 mg per dose, twice daily) + Vonoprazan (20 mg per dose, once daily), 14-day co
Group B: Amoxicillin (1000 mg per dose, three times daily) + Vonoprazan (20 mg per dose, once daily):Group B: Amoxicillin (1000 mg per dose, three times a day) + Vonoprazan (20 mg per dose, once dail

Sponsors

Fuzhou University Affiliated Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 Adult patients aged between 60 and 80 years. 2 No prior use of an amoxicillin-containing regimen for Helicobacter pylori eradication before treatment, and no intake of antibiotics, bismuth preparations, or traditional Chinese medicine within 4 weeks before treatment, or proton pump inhibitors (PPIs), H2 receptor antagonists, or similar medications within 2 weeks before treatment. 3 Diagnosis of H. pylori positivity confirmed by C13 or C14 urea breath test or rapid urease test. 4 Patients were informed and agreed to participate in the study, with complete medical records and follow-up data.

Exclusion criteria

Exclusion criteria: Patients with severe primary diseases of the heart, lungs, kidneys, liver, or hematopoietic system, or those with compromised immunity. Those with contraindications due to drug allergies. Individuals with mental illnesses or communication disorders. Patients with organic lesions such as gastrointestinal tumors or gastrointestinal bleeding.

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
Degree of clinical symptom remission;Adverse reaction;

Countries

China

Contacts

Public ContactXueping Huang

Fuzhou University Affiliated Provincial Hospital

hxuep@mail2.sysu.edu.cn+86 157 5081 9302

Outcome results

None listed

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