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临床试验/NCT04617613
NCT04617613已完成4 期

Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait

Al-Azhar University0 个研究点目标入组 603 人开始时间: 2016年9月最近更新:
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
603
主要终点
Negative 13-Carbon urea breath test

研究概览

简要总结

Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait.

详细描述

Helicobacter pylori (H. pylori) induced chronic infection is associated with peptic ulcer, chronic gastritis, gastric cancer, and increasing antibiotic resistance. Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer in the high-risk population. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait. We enrolled treatment-naive dyspeptic patients with gastric biopsy-proven chronic gastritis secondary to H. pylori in a prospective, open-label, randomized study conducted at the gastroenterology outpatient clinics of Haya Habeeb gastroenterology center in Kuwait. Patients were randomized into two groups: the first group received the standard triple therapy (omeprazole, amoxicillin, and clarithromycin) for 14 days; and the second group received quadruple therapy (omeprazole, amoxicillin, clarithromycin, and metronidazole) for 14 days. All patients were tested for the eradication of H. pylori by carbon-13 urea breath test (13C-UBT) one month after completion of eradication therapy.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female dyspeptic subjects aged ≥18 years with any nationality
  • Patients with gastric biopsy-proven H. pylori related chronic gastritis and no other abnormalities in the upper gastrointestinal tract upon endoscopy
  • Patients who were naive to treatment for H. pylori infection.

排除标准

  • Pregnant or breastfeeding females
  • Patients who were previously treated for H. pylori infection
  • Patients who received any antibiotics, bismuth or acid-suppressant drugs within the last month

研究组 & 干预措施

Standard triple therapy

Active Comparator

Standard triple therapy group received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg twice daily for 14 days.

干预措施: Omeprazole, Amoxicillin and Clarithromycin (Drug)

Quadruple therapy group

Experimental

Quadruple therapy group received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily after meals for 14 days.

干预措施: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin (Drug)

结局指标

主要结局

Negative 13-Carbon urea breath test

时间窗: One month

H. pylori eradication rate defined as negative 13-Carbon urea breath test (13C-UBT) one month after treatment

Adverse events

时间窗: One month

Any reported adverse events during the study period

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

Mohamed Alboraie

Postgraduate clinical researcher

Al-Azhar University

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