Comparative Effectiveness of Triple Versus Quadruple Therapy in the Treatment of Helicobacter Pylori Induced Gastritis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 752
- 试验地点
- 1
- 主要终点
- Eradication of Helicobacter pylori infection six weeks post-treatment
研究概览
简要总结
This randomized controlled trial is designed to compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy for the eradication of Helicobacter pylori-induced gastritis. The study is being conducted at Shahida Islam Medical College, Lodhran, Pakistan. Adult patients with confirmed H. pylori infection are randomly allocated to receive either a 14-day triple therapy regimen or a 14-day bismuth-based quadruple therapy regimen. Eradication of H. pylori is assessed six weeks after completion of treatment using stool antigen testing. The primary outcome measure is the proportion of patients achieving successful eradication of H. pylori.
详细描述
Background:
Helicobacter pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric malignancy. Standard triple therapy has historically been used as first-line treatment; however, increasing antibiotic resistance has led to declining eradication rates in many regions. Bismuth-based quadruple therapy has emerged as an alternative regimen and is recommended in areas with suspected or confirmed antibiotic resistance.
Objective:
To compare the efficacy of standard triple therapy versus bismuth-based quadruple therapy in achieving eradication of Helicobacter pylori in adult patients with H. pylori-induced gastritis.
Study Design and Methods:
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
- •Adults aged 18-65 years.
- •Confirmed Helicobacter pylori infection based on a positive stool antigen test.
- •Willing and able to provide written informed consent.
排除标准
- •History of allergy or hypersensitivity to any of the study drugs (omeprazole, amoxicillin, clarithromycin, metronidazole, tetracycline, or bismuth compounds).
- •Prior H. pylori eradication therapy.
- •Pregnancy or lactation.
- •History of gastrointestinal bleeding, peptic ulcer perforation, or prior gastric surgery.
- •Chronic renal failure or hepatic dysfunction.
- •Current use of proton pump inhibitors or antibiotics within the previous six weeks.
- •Use of traditional (Hakeem) medications or herbal remedies affecting gastric function.
- •Psychiatric illness or inability to comply with treatment and follow-up.
研究组 & 干预措施
Triple Therapy Group
Participants received Omeprazole 40 mg twice daily, Amoxicillin 1 g twice daily, and Clarithromycin 500 mg twice daily for 14 days.
干预措施: Triple Therapy (Drug)
Quadruple Therapy Group
Participants received Omeprazole 40 mg twice daily, Metronidazole 400 mg three times daily, Tetracycline 500 mg every six hours, and Bismuth subsalicylate for 14 days.
干预措施: Quadruple Therapy (Drug)
结局指标
主要结局
Eradication of Helicobacter pylori infection six weeks post-treatment
时间窗: 6 weeks after treatment completion
Eradication was assessed by stool antigen testing six weeks after completion of therapy. A negative stool antigen test indicated successful eradication.
次要结局
未报告次要终点
研究者
Azfar Farogh
Professor of Medicine
Shahida Islam Medical Complex