A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of patients with eradicated helicobacter
研究概览
简要总结
Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.
Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .
However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.
Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .
详细描述
Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.
Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth [11]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with helicobacter infection.
- •in whom the standard triple therapy (clarithromycin-based triple therapy) failed
排除标准
- •Patients under 18 or over 65 years of age.
- •Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
- •pregnancy/lactation
- •having contraindication or allergy to any of the study drugs
研究组 & 干预措施
Quadruple therapy
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
干预措施: Nitazoxanide (Drug)
Quadruple therapy
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
干预措施: Levofloxacin (Drug)
Quadruple therapy
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
干预措施: Doxycyclin (Drug)
Quadruple therapy
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
干预措施: Omeprazole (Drug)
结局指标
主要结局
Number of patients with eradicated helicobacter
时间窗: 1 year
The total number of patients with eradicated helicobacter
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Hepatology and Gastroenterology Dept., Tanta university, M.D., Principle investigator
Tanta University