Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

recommendations for Hp eradication treatment: A high-risk Hp subtype guidance group consisting of the receiving physician + trial-related personnel conducts individualized assessment based on Hp infection, SNP test results, gastric mucosa condition, medical history and other factors, and provides subjects with medical explanations and recommendations for eradication treatment. Eradication group protocol: standard quadruple therapy for H. pylori eradication program (PPI + bismuth + two antibiotics) 1. Omeprazole (or esomeprazole): 20mg, 2 times/day 2. Bismuth citrate: 220mg, 2 times/day 3. Metronidazole: 400mg, 3 times/day 4. Tetracycline: 500mg, 3 times/day 5. Treatment cycle: 10-14 days Eradication success was assessed after 1 month by urea breath test (UBT) or Hp fecal antigen test.

Study summary

This study is a prospective, multicenter cluster randomized controlled trial. Additional fecal screening for high-risk SNP subtypes, in conjunction with routine Hp testing, may improve the identification of individuals at high risk for gastric cancer. Moreover, the implementation of eradication interventions in high-risk groups has the potential to significantly reduce the incidence and progression of gastric cancer.

Eligibility

Primary outcome measure(s)

• Five-year gastric cancer incidence in both groups — Through study completion, an average of 5 to 10 years
  To compare the incidence of gastric cancer between the two groups during the follow-up period to assess the impact of the eradication strategy on the prevention of gastric cancer.

Trial sites (1)

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