Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection -an Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To compare the eradication rate of Helicobacter pylori infection between quadruple therapy and triple therapy among dyspeptic patients
研究概览
简要总结
The Goal of this this clinical trial is to assess and compare the eradication rate of triple and quadruple therapy during treating helicobacter pylori infection among patients presented with dyspepsia. It will also assess the patient reported adverse events among two groups.
H pylori infection will be confirmed by CLO (RUT) test and stool antigen test both.
Standard triple therapy will be based on Esomeprazole 20 mg BD, Clarithromycin 500mg BD and Amoxicillin 1gm BD. Bismuth Quadruple therapy consists of Bismuth subcitrate 120mg QDS, Tetracycline 500mg QDS and Metronidazole 500mg TDS. Patient will be confirmed H pylori eradication 4 weeks after completion of treatment by Stool antigen test only.
详细描述
This Randomized Controlled Trial study aims to compare the eradication rates of Helicobacter pylori infection between quadruple therapy and triple therapy in dyspeptic patients at Dhaka Medical College & Hospital.
Sixty-Six participants, selected through purposive sampling, will be randomly allocated into two groups: 33 patients in Group A (receiving Triple therapy) and 33 in Group B (receiving Quadruple therapy). After pre-procedural preparation, a CLO test will be conducted during endoscopy and a stool antigen test to detect H. pylori. Participants will undergo treatment for 14 days, followed by follow-up testing 6 weeks later to evaluate eradication. Ethical approval will be obtained, and confidentiality will be maintained.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All dyspeptic patients aged ≥18 years.
- •Patients who will provide informed written consent and agree to follow-up at 4 weeks post-treatment.
排除标准
- •Patients who have received prior H. pylori eradication therapy.
- •Ingestion of antibiotics or proton pump inhibitor within the prior 4 weeks. Patient who will test negative either of CLO or Stool Antigen Test or both
- •Patients with known allergies or intolerance to any of the study medications.
- •Patients with alarm symptoms (e.g., unexplained weight loss, persistent vomiting, dysphagia).
- •Patients with a history of gastric surgery.
- •Pregnant or lactating women.
研究组 & 干预措施
Triple drug Therapy
Triple drug therapy includes Amoxicillin , clarithromycin and esomeprazole
干预措施: Triple drug regimen (Drug)
Quadruple therapy
Bismuth Metronidazole Tetracycline Esomeprazole
干预措施: Quadruple therapy (Drug)
结局指标
主要结局
To compare the eradication rate of Helicobacter pylori infection between quadruple therapy and triple therapy among dyspeptic patients
时间窗: 1 month
次要结局
- 1. To determine the eradication rate of H. pylori in patients receiving triple drug therapy. 2. To determine the eradication rate of H. pylori in patients receiving quadruple therapy. 3. Assess and quantify patient reported adverse events in both groups(1 month)
研究者
Akil Al Islam
Principal Investigator
Dhaka Medical College