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A multicenter randomized controlled study on the efficacy of vonoprazan combined with high-dose amoxicillin dual therapy for first-line eradication of Helicobacter pylori in the Qinghai region.

A Multicenter Controlled Study on Modified Vonoprazan Combined with High-Dose Amoxicillin Dual Therapy for First-Line Eradication of Helicobacter pylori

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116011
Enrollment
Unknown
Registered
2026-01-04
Start date
2026-01-04
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Helicobacter pylori infection

Interventions

14-day quadruple therapy:Omeprazole 20 mg BID + Amoxicillin 1 g BID + Clarithromycin 500 mg BID + Bismuth agent 200 mg BID
Modified Vonoprazan Combined with High-Dose Amoxicillin Dual Therapy:Vonoprazan 20 mg BID + Amoxicillin 1 g TID for 10 days

Sponsors

Qinghai Provincial Xining Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 75 years, inclusive, regardless of gender. 2. Positive test result: A positive ¹³C- or ¹4C-urea breath test result within one month prior to enrollment. 3. Diagnosis and indication: Patients diagnosed with Helicobacter pylori-positive chronic gastritis by gastroscopy within three months, who meet the criteria for H. pylori eradication as recommended by the Sixth Chinese National Consensus Report on the Management of Helicobacter pylori Infection, and are willing to undergo eradication therapy. 4. Treatment-naïve: No prior history of H. pylori eradication therapy. 5. Informed consent: Signed informed consent form must be obtained.

Exclusion criteria

Exclusion criteria: Patients allergic to any of the study drugs. 2. Patients who have used Vonoprazan (or other PCABs), PPIs, H2-receptor antagonists, antibiotics, bismuth agents, or probiotic preparations within one month prior to treatment initiation. 3. Pregnant or lactating women, or patients planning pregnancy during the study period. 4. Patients requiring use of NSAIDs, adrenal corticosteroids, or anticoagulants during the study period. 5. Patients with severe concurrent diseases that may interfere with the study evaluation, such as cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric diseases, or malignant tumors. 6. Patients with a history of gastric or esophageal surgery. 7. Patients unlikely to complete follow-up or with other factors that may compromise compliance.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Compliance;

Countries

China

Contacts

Public ContactAng Cheng

Qinghai Provincial Xining Third People's Hospital

364277217@qq.com+86 155 9739 8975

Outcome results

None listed

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