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临床试验/NCT05701683
NCT05701683已完成4 期

IMPROVEMENT in ERADICATION of H-PYLORI INFECTION With ADDITION of LACTOBACILLUS REUTERI

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2019年11月15日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Mehreen Akmal

Principal Investigator

Liaquat National Hospital & Medical College

研究点 (1)

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