IMPROVEMENT in ERADICATION of H-PYLORI INFECTION With ADDITION of LACTOBACILLUS REUTERI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Eradication rate
研究概览
简要总结
Efficacy in terms of H pylori eradication of clarithromycin based sequential therapy with lactobacillus is better than sequential based therapy alone.
详细描述
Data Collection:
Subjects attending outpatient in department of Gastroenterology meeting the inclusion & exclusion criteria in Liaquat National Hospital, Karachi with H. pylori related chronic gastritis with/without peptic ulcers on endoscopy & gastric biopsy (histopathology) or Stool for H. pylori antigen +ve, or Rapid urease test +ve or Positive Urea Breath Test as per operational definition will be included. For all patients included in this study, we will collect the following information age, gender, duration of the disease.Patients will be divided into two groups randomly, group A and B.In group A (case) patients along with standard sequential therapy :
- Amoxil 1000 mg twice daily for first 5 days
- clarithromycin 500 mg twice daily plus Tinidazole 500 mg twice daily for next 5 days with addition of lactobacillus R 100 mg twice daily in capsule form will be given for 2 weeks. While group B (control) will include patients who have already received standard sequential therapy which is
- Amoxil 1000mg twice daily for first 5 days
- Clarithromycin 500 mg twice daily plus Tinidazole 500 mg twice daily for next 5 days After completion of 6 weeks of proton pump inhibitors (PPI), it will be stopped. As per our protocol for all patients , after 1-2 weeks of stopping PPI stool sample will be collected and will be sent to the laboratory of the institute for helicobacter pylori stool antigen (HPSA).This test is performed as routine to check the success of eradication therapy. H. pylori eradication will be achieved if post treatment HPSA is negative. All demography, clinical history will be recorded by a principal investigator on a predesigned proforma, informed written consent will be taken before enrolment. Exclusion criteria will be followed strictly to avoid confounding variables.
MATERIAL AND METHODS
Study design:
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18 years to 60 years of age.
- •Either gender
- •Patients having H. pylori related chronic gastritis with/without peptic ulcers on endoscopy & gastric biopsy (histopathology) or Stool for H. pylori antigen +ve , or Rapid urease test +ve
排除标准
- •Pregnant women
- •End stage renal disease (GFR <15 mL/min/)
- •Chronic Liver Disease
研究组 & 干预措施
ERADICATION of H-PYLORI INFECTION with ADDITION of LACTOBACILLUS REUTERI
In experimental group, patients receiving clarithromycin based sequential therapy with LACTOBACILLUS REUTERI
干预措施: Lactobacillus Reuteri Probiotic (Drug)
结局指标
主要结局
Eradication rate
时间窗: 8 weeks after therapy
eradication of helicobacter pylori infection after 8 weeks of completion of therapy
次要结局
未报告次要终点
研究者
Dr.Mehreen Akmal
Principal Investigator
Liaquat National Hospital & Medical College
