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临床试验/CTRI/2024/09/074495
CTRI/2024/09/074495招募中不适用

Comparison of Vonoprazan based therapy vs Standard Quadruple therapy for eradication of Helicobacter pylori

NBE1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月7日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Comparison of eradication rate of H. Pylori between the two regimens.

研究概览

简要总结

Helicobacter pylori (H. pylori) infection is a general condition that is usually lifelong, with a prevalence reaching approximately 50% worldwide; in China, the prevalence has recently reached 44%. In December 2021, th.e U.S. Department of Health and Human Services listed chronic H. pylori as a clear carcinogen in the 15th report on carcinogens. It has also been proven to be closely related to multiple gastrointestinal (GI) diseases such as gastric adenocarcinoma, peptic ulcer (gastric and duodenal ulcer), chronic gastritis, and mucosa-associated lymphoid tissue (MALT) lymphoma. Successful H. pylori eradication would not only benefit individuals by improving histologic gastritis, preventing gastric carcinogenesis, and reducing the risk of serious complications but also block transmission and alleviate future medical expenses. However, H. pylori eradication rates have been decreasing in recent years, while the antibiotic resistance rate continues to increase.

Hence vonoprazan a novel potassium channel blocker, may be effective as a component of H. pylori eradication therapy. Vonoprazan therapy is approved for H pylori eradication and is currently being used in practice. We at our centre prescribe both the regimens. Patients will be prescribed treatment for 14 days. Confirmation of H. Pylori eradication will be done by stool H pylori antigen test or urea breadth test at 4 weeks at the end of h pylori treatment. Data of the patients taking quadruple therapy and vonoprazan therapy will be collected. Then H.Pylori eradication rate of  both the regimens will be calculated and then will be compared

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18-80 years
  • All symptomatic patients with dyspepsia (ROME criteria 4)with proven h pylori on biopsy/ urea breath test/stool for h pylori ROME 4 CRITERIA
  • One or more of the following:
  • Bothersome postprandial fullness
  • Bothersome early satiation
  • Bothersome epigastric pain
  • Bothersome epigastric burning AND
  • No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis).

排除标准

  • Patients with the following findings will be excluded from the study
  • H/o gastric surgery such as partial gastrectomy
  • H/o allergy of drugs used in the study
  • Pregnant and lactating females
  • Alcohol or drug addiction
  • Lack of informed consent.

结局指标

主要结局

Comparison of eradication rate of H. Pylori between the two regimens.

时间窗: 2 WEEKS

次要结局

未报告次要终点

研究者

发起方
NBE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Mohinish Chhabra

Fortis hospital, Mohali

研究点 (1)

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