A Comparative Study Between Concomitant Versus Load Therapy in Eradication of Helicobacter Pylori Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Eradication of H. pylori infection after treatment
研究概览
简要总结
All patients who presented with epigastric pain and dyspeptic symptoms will undergo endoscopic gastric biopsies.
The patients will be subjected to: Full history taking, clinical examination, liver function tests, renal function tests, CBC, INR, abdominal ultrasonography.
About 200 patients diagnosed to have H. pylori by infection by microscopically examined, endoscopic gastric biopsies will be enrolled in our study.
All available formalin fixed and paraffin embedded tissue blocks of gastric endoscopic biopsies will be resectioned and stained with Haematoxylin and Eosin. Modified Giemsa stain, and Alcian blue/ PAS stain will be used for verification of Helicobacter pylori and demonstration of intestinal metaplasia respectively.
Biopsies will be classified using the Updated Sydney system of classification of gastritis
详细描述
The patients will be randomized (closed envelopes) into one of two groups:
- patients will receive concomitant therapy comprising of pantoprazole (40 mg twice daily), amoxicillin (1 gm twice a day), clarithromycin (500 mg twice a day) and metronidazole (500 mg twice a day) for 2 weeks.
- patients will receive LOAD therapy comprising of levofloxacin (250 mg with breakfast), omeprazole (40 mg before breakfast), nitazoxanide (Alina) (500 mg twice daily with meals) and doxycycline (100 mg at dinner) for 10 days.
H. Pylori eradication will be confirmed by H. Pylori stool antigen testing at least 4 weeks after cessation of antibiotic therapy with stoppage of PPI therapy at least one to two weeks.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who presented with epigastric pain and dyspeptic symptoms
排除标准
- •Patients recently (within 6 months) treated with anti-H. pylori therapy.
- •Allergy to any drugs used in our protocol
- •Patients on PPI, antibiotics, and steroid or non-steroidal anti-inflammatory drugs within past one month before randomization.
- •Concomitant significant comorbidities (advanced cardiac, renal, hepatic disease).
- •Presence of GI malignancy.
- •Pregnancy or lactating women.
- •Unable or refuse to give consent. -
研究组 & 干预措施
concomitant
Clarithro -pantoprazole- Metronidazole - Amoxicyllin
干预措施: Comparing Load and Concomitant therapy (Drug)
LOAD
Levofloxacin -omeprazole- nitazoxanide- Doxycycline
干预措施: Comparing Load and Concomitant therapy (Drug)
结局指标
主要结局
Eradication of H. pylori infection after treatment
时间窗: 4 weeks after end of treatment
Negative stool antigen test for H.pylori
次要结局
未报告次要终点
研究者
Hala Hany Shehata
Principle Investigator
Helwan University