Efficacy and safety of body size guided dual therapy in treating Helicobacter pylori infection

Efficacy and safety of individualized dual therapy in treating Helicobacter pylori infection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400089491

Enrollment

Unknown

Registered

2024-09-10

Start date

2024-09-15

Completion date

Unknown

Last updated

2024-09-16

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:body size guided dual therapy, which consists of amoxicillin with body size guided dosage (BMI24: 3g/d) plus vonoprazon 40mg/d

Control Group:high dose dual therapy, which consisted of amoxicillin (3g/d) plus vonoprazon (40mg/d)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

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, and (4) 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

Measure	Time frame
Eradication rate of Helicobacter pylori;	—

Secondary

Measure	Time frame
Side effects rates;Compliance of Treatment;	—

Countries

China

Contacts

Public ContactXiao-Bei Si

Beijing Jishuitan Hospital, Capital Medical University

sixiaobei2008@126.com+86 10 5839 8289

Outcome results

None listed

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