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Efficacy and Safety of a 10-Day Dual Therapy with Vonoprazan and High-Dose Amoxicillin for Helicobacter pylori Eradication: A Multicenter, Controlled Study in Han and Ethnic Minority Populations

Efficacy and Safety of a 10-Day Dual Therapy with Vonoprazan and High-Dose Amoxicillin for Helicobacter pylori Eradication: A Multicenter, Controlled Study in Han and Ethnic Minority Populations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113950
Enrollment
Unknown
Registered
2025-12-04
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Helicobacter pylori infection

Interventions

Patients from Changzhou (Han) :Vonoprazan 20mg twice daily + Amoxicillin 1000mg three times daily for 10 days
Qinghai (Han):Vonoprazan 20mg twice daily + Amoxicillin 1000mg three times daily for 10 days
Qinghai (Tibetan):Vonoprazan 20mg twice daily + Amoxicillin 1000mg three times daily for 10 days
Qinghai (Hui):Vonoprazan 20mg twice daily + Amoxicillin 1000mg three times daily for 10 days

Sponsors

Changzhou Wujin People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years, regardless of gender. 2. Of Han, Hui, or Tibetan ethnicity. 3. Positive for Helicobacter pylori (H. pylori) infection confirmed by a 13C- or 14C-urea breath test within one month. 4. Participants with a diagnosis of H. pylori-positive chronic gastritis confirmed by gastroscopy within three months, who meet the indications for H. pylori eradication as recommended by the Sixth National Consensus Report on the Management of H. pylori Infection, and are willing to undergo eradication therapy. 5. No history of prior H. pylori eradication treatment. 6. Provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants with a known allergy to any of the drugs used in this study. 2. Use of Vonoprazan, PPIs, H2-receptor antagonists, antibiotics, bismuth agents, or probiotic preparations within one month prior to treatment initiation. 3. Women who are pregnant or breastfeeding, or participants planning a pregnancy during the study period. 4. Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period. 5. Presence of severe concomitant diseases that may interfere with the study evaluation, including cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric diseases, as well as malignant tumors. 6. History of previous gastric or esophageal surgery. 7. Inability to complete the required follow-up or presence of any other factors that may compromise adherence to the study protocol.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori eradication rate;

Secondary

MeasureTime frame
Compliance;

Countries

China

Contacts

Public ContactPeipei Luo

Changzhou Wujin People's Hospital

luopeipei@wjrmyy.cn+86 158 5197 9739

Outcome results

None listed

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