A Randomized Controlled Trial of Triple Therapy With Conventional Proton Pump Inhibitor vs Triple Therapy With Vonoprazan as First Line Therapy for Helicobacter Pylori Gastritis
试验速览
- 阶段
- 4 期
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Eradication rates of Helicobacter pylori determined by Carbon-13 urea breath test or biopsy
研究概览
简要总结
Helicobacter pylori (H. pylori) gastritis is a common bacterial infection among the elderly population. H. pylori infection causes chronic progressive gastric inflammation, peptic ulcer disease and gastric cancer. Gastric cancer is a significant contributor of cancer-related mortality. The eradication of H. pylori reduces the incidence of gastric cancer. However, the efficacy of H. pylori eradication has decreased dramatically because of antibiotic resistance. This study aims to (i) compare the eradication rates of H. pylori by triple therapy with vonoprazan for the treatment of H. pylori gastritis) (TTV regimen), with triple therapy with conventional proton pump inhibitor (PPI) (TTP regimen) in a multi-racial Asian cohort, (ii) evaluate the prevalence of antibiotic (klacid/amoxicillin/levofloxacin/tetracycline) resistance in H. pylori infected patients, and (iii) assess the safety of the TTV regimen. Diagnosed H. pylori-infected patients (n=252) will be enrolled and randomized 1:1 to TTV or TTP regimen. Gastric biopsies will be cultured and antibiotic sensitivity evaluated using E-test/agar dilution method. The safety of TTV regimen will be assessed using adverse effect questionnaire. This study may potentially impact on prescribing policies and management of H. pylori infections for improved therapeutic outcome.
详细描述
All subjects who present for endoscopy will be screened. Consent will be taken from subjects who are scheduled to undergo gastroscopy. Gastric biopsies to test for the presence of H. pylori using the rapid CLO test and for culture and sensitivity will be obtained. Based on an estimated prevalence of H. pylori of 20%, we aim to screen approximately 1000 subjects for H. pylori with the rapid CLO test during gastroscopy.
Subjects who have a negative CLO test during endoscopy will be excluded from the study and will be managed accordingly by their physician.
Subjects who are confirmed to have H. pylori gastritis based on the CLO test will then be recruited into the study.
Diagnosed H. pylori positive patients (n=252) will be enrolled into four study groups:
- Group A: Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
- Group B: Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
- Group C: Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
- Group D: Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed to have H. pylori infection from the Gastroenterology and Hepatology Clinic or ward from Changi General Hospital, The diagnosis of H. pylori infection is established based on either a positive carbon urea breath test (CUBT), a positive rapid urease test, or histology in patients who undergo a diagnostic upper gastrointestinal endoscopy.
- •Asian (Chinese, Malay or Indian) ancestry as defined by NRIC,
- •Aged ≥ 21 years of age,
- •Provision of written informed consent,
- •Willing to provide a blood sample for genotyping,
- •Ability to communicate with the investigator and to understand and comply with all requirements of study participation.
排除标准
- •Known allergy to any of the treatment drugs,
- •Inability to undergo routine test to confirm success of H. pylori eradication,
- •Previous failed H. pylori therapy,
- •Pregnancy or lactation,
- •Declare themselves positive for HIV or viral hepatitis (Hepatitis A, B, C),
- •Treatment within the previous 3 months with antibiotics.
研究组 & 干预措施
TTP (Group A)
Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
干预措施: Omeprazole 20mg (Drug)
TTP (Group B)
Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
干预措施: Esomeprazole 20mg (Drug)
TTP (Group C)
Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
干预措施: Rabeprazole Sodium 20mg (Drug)
TTP (Group D)
Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days
干预措施: Vonoprazan (Drug)
结局指标
主要结局
Eradication rates of Helicobacter pylori determined by Carbon-13 urea breath test or biopsy
时间窗: 6-8 weeks
Compare eradication rates of Helicobacter pylori by triple therapy with conventional proton pump inhibitor (Omeprazole/ Esomeprazole/ Rabeprazole) (TTP regimen) vs triple therapy with Vonoprazan (TTV regimen) in a multi-racial Asian cohort, using Carbon-13 urea breath test or biopsy
次要结局
- Prevalence of antibiotic resistance based on E-test (Minimum Inhibitory Concentrations)(6-8 weeks)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](8 weeks)
- Association of CYP2C19 genotypes with triple therapy efficacy(Through study completion, an average of 2 years)