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Efficacy and Metabolic Effects of Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pyloriEradication in Patients with Type 2 Diabetes Mellitus: A Prospective, Randomized, Non-inferiority Trial

Efficacy and Metabolic Effects of Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pyloriEradication in Patients with Type 2 Diabetes Mellitus: A Prospective, Randomized, Non-inferiority Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083573
Enrollment
Unknown
Registered
2024-04-28
Start date
2024-06-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Helicobacter pylori infection

Interventions

The bismuth quadruple therapy group:Bismuth quadruple therapy for 14 days:esomeprazole 20mg bid(30 minutes before meals),amoxicillin 1000mg bid(30 minutes after meals),clarithromycin 500mg bid (30 min
The vonoprazan and high-dose amoxicillin dual therapy group:The vonoprazan and high-dose amoxicillin dual therapy for 14 days:vonoprazan 20mg bid(30 minutes before meals) and amoxicillin 750mg 4 times

Sponsors

Jiangsu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–85 years with a confirmed diagnosis of type 2 diabetes mellitus (according to the Standards of Care in Diabetes—2024 by the American Diabetes Association [ADA]); 2. Active Helicobacter pylori (H. pylori) infection confirmed by a positive 13C-urea breath test (13C-UBT); 3. No prior history of H. pylori eradication therapy; 4. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with a known allergy or hypersensitivity to the medications used in this study; 2. Use of Vonoprazan (Vocinti), proton pump inhibitors (PPIs), H2 receptor antagonists, antibiotics, bismuth agents, or traditional Chinese medicines with antibacterial effects within 4 weeks prior to treatment; 3. History of gastrectomy or gastric malignancies; 4. Gastroduodenal ulcer with recent bleeding or signs of bleeding within the past 4 weeks; 5. Pregnant or lactating women, or patients with plans to conceive during the study period; 6. Presence of severe concomitant diseases that could affect the evaluation of this study (e.g., cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric diseases, malignant tumors, etc.); 7. Difficulty in completing follow-ups or other factors that may affect compliance/adherence.

Design outcomes

Primary

MeasureTime frame
Eradication rate;

Secondary

MeasureTime frame
Blood sugar control;Compliance;Incidence of Adverse Reactions;

Countries

China

Contacts

Public ContactZhou Xiaoying

Jiangsu Province Hospital

zhouxiaoying0926@sina.cn+86 158 5066 8395

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 9, 2026