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临床试验/NCT06315478
NCT06315478已完成4 期

Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians

Helwan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月1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
60
试验地点
1
主要终点
stool antigen retest

研究概览

简要总结

Our study aimed to investigate the efficacy and safety of hybrid regimen as a first line therapy for H. pylori eradication compared to triple and quadruple regimens in attempt to overcome antibiotic resistance

详细描述

Helicobacter pylori (H. pylori) is a globally prevalent pathogen which infects about over 50% of population. However, not all cases have clinical symptoms, H. pylori are described as gram negative bacteria which causes ulcers in the lining of stomach or the upper part of small intestine. For some patients, a progressive infection can cause gastric cancer which is the second widespread cancer worldwide (1).

While this pathogen in Egypt is a public health issue, the propagation of H. pylori infection is approximately 80% (2), study results concluded that H. pylori infection in upper Egypt was higher than in urban areas (3).

Transmission modes of H. pylori are very controversial, the reservoir of H. pylori is the human stomach. The main method of acquisition in both developing and developed countries by fecal oral route, whereas the other route of transmission in developed countries is the gastro-oral route mainly water borne prevalence, overcrowding of the family of large number members, institutionalized children are predisposing for acquiring the infection. (4:6), and occupational risk factor for health members, in particular those working in gastrointestinal units (7). Over spread of the infection in upper Egypt could be due to the hygiene level, socioeconomic conditions, life style, and absence of sources of pure water supply in rural areas (3).

H. pylori has been classified as one of the 12 bacterial species need high priority future strategies for new antibiotic development by the World Health Organization (WHO), management of H. pylori is widely debatable due to high antibiotics resistance prevalence after exclusion of inadequate gastric suppression by proton pump inhibitor and poor adherence to the therapy. Furthermore, the efficacy of many regimens has declined due to increased antibiotic resistance making H. pylori eradication challenging, H. pylori treatment has been complicated and has required 10 and 14 days of multiple daily doses of three or four different medicines. (8:13).

There is no worldwide accepted regimen for the eradication of H. pylori infection. Standard triple therapy (STT) with proton pump inhibitors (PPI) in standard dose, clarithromycin (500 mg), and amoxicillin (1 g) twice daily for 14 days is the standard triple first line regimen in the published international guidelines of the European Helicobacter and Microbiota Study Group in areas of low clarithromycin resistance (14).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
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

  • Naïve patients
  • adult >18 years
  • Patients with positive SAT
  • Patients didn't take any antibiotics for the previous 4 weeks or PPI for the previous 2 weeks
  • Patients diagnosed with duodenal ulcers who have H. pylori infection and treated with triple or quadruple regimens for H. pylori

排除标准

  • 1-Patients had any concern with triple or quadruple regimens such as hypersensitivity to any of the drug 2-Pregnancy or lactation 3-Refusal to sign the informed consent.

研究组 & 干预措施

Triple regimen(Group A)

Active Comparator

干预措施: Omeprazole 20 MG Oral Tablet (Drug)

Quadruple regimen (Group B)

Active Comparator

干预措施: Amoxicillin 500Mg Tab (Drug)

Hybrid regimen (Group C)

Active Comparator

干预措施: Clarithromycin 500Mg Tab (Drug)

结局指标

主要结局

stool antigen retest

时间窗: 6 weeks

efficacy of the regimen by eradication of H. pylori

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

Donia Mohamed Eid

bachelor graduate at pharmacy university

Helwan University

研究点 (1)

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