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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056933
Enrollment
94
Registered
2025-02-05
Start date
2024-12-06
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Helicobacter pylori infection

Interventions

Experimental group: Paitients accept body size guided dual therapy, which consists of amoxicillin with body size guided dosage (BMI&lt
18.5: 2g/d
=18.5 and BMI&lt
20.33: 2.25g/d
=20.33 and BMI&lt
22.16: 2.5g/d
=22.16 and BMI&lt
=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).

Sponsors

Beijing Jishuitan Hospital Nova Program
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) positive for either the 13C-urea breath test (13C-UBT) and/or positive pathological section staining of H. pylori within the past 3 months, and the diagnostic process meets the criteria of the Sixth National Consensus on the Management of Helicobacter pylori Infection; (2) no history of treatment with H. pylori eradication, (3) aged 18-70 years old, (4) BMI<=24kg/m2, and (5) fully informed and agreed to participate in this study.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Eradication rate of Helicobacter pylori

Countries

Asia(except Japan)

Contacts

Public ContactXiao-Bei Si

Beijing Jishuitan Hospital, Capital Medical University Departement of Gastroenterology

sixiaobei2008@126.com+86-10-58398289

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026