Efficacy and safety of precise dual therapy as first-line treatment for H. pylori infection in non-overweight patients

UMIN ID: UMIN000056933

Registered date:05/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Helicobacter pylori infection
• Date of first enrollment: 2024/12/06
• Target sample size: 94
• Countries of recruitment: Asia(except Japan)
• Study type: Interventional

Intervention(s)

Experimental group: Paitients accept body size guided dual therapy, which consists of amoxicillin with body size guided dosage (BMI<18.5: 2g/d; BMI>=18.5 and BMI<20.33: 2.25g/d; BMI>=20.33 and BMI<22.16: 2.5g/d; BMI>=22.16 and BMI<=24: 2.75g/d) plus vonoprazon 40mg/d
Control group: Paitients accept high dose dual therapy, which consisted of amoxicillin (3g/d) plus vonoprazon (40mg/d).

Outcome(s)

• Primary Outcome: Eradication rate of Helicobacter pylori

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: (1) received medications that might affect the study results up to 4 weeks prior to enrollment, including H2 receptor antagonists, proton pump inhibitors, competitive potassium pump blockers, bismuth agents, or antibiotics (2) patients with any current complications with additional medication required, such as malignant tumors, digestive ulcers, gastrointestinal bleeding, reflux esophagitis; (3) patients with a history upper gastrointestinal surgery; (4) patients with systemic diseases, including severe liver or kidney damage; (5) patients allergic to the medicines used in this study; (6) women who were pregnant or lactating; (7) patients with long-term use of glucocorticoids or nonsteroidal anti-inflammatory medicines; and (8) patients with mental abnormalities who had difficulties cooperating with the investigator.

Related Information

• Primary Sponsor: Beijing Jishuitan Hospital Nova Program
• Source(s) of Monetary Support: Beijing Jishuitan Hospital, Capital Medical University