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Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Recruiting
18 - 70 years of age
Both
Phase 4

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Overview

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Description

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Eligibility

Inclusion Criteria:

  1. Ages between 18 and 70 years; Sexes eligible for study: both;
  2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
  3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
  4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

  1. allergic reactions to the study drugs;
  2. patients with peptic ulcer;
  3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
  4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
  5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
  6. patients who have history of esophageal or gastric surgery;
  7. pregnant or lactating women;
  8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
  9. Alcohol abusers
  10. MALT lymphoma of stomach or malignant tumor

Study details

Helicobacter Pylori Infection

NCT05649540

Nanjing First Hospital, Nanjing Medical University

1 June 2024

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