Nitazoxanide and Lansoprazole Based Regimens for Managing Helicobacter Pylori in Egyptian Patients (NILE Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA).
研究概览
简要总结
The study will evaluate the eradication rate and tolerability of modified LOAD regimens (three antibiotics and a proton pump inhibitor (lansoprazole)) for management of HP infection in treatment-naive patients as well as patients who failed previous therapies.
详细描述
This will be randomized, parallel group, comparative open-label study that will be conducted to evaluate the efficacy and tolerability of a four-drug regimen (modified LOAD regimen) in eradicating HP. The study will evaluate the efficacy of modified LOAD regimens(levofloxacin/moxifloxacin, nitazoxanide, doxycycline and lansoprazole) inpatients who failed previous therapies and compare these regimens with the classic triple therapy (amoxicillin, clarithromycin and lansoprazole) in treatment naïve patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presented with dyspepsia for more than one month with positive H. pylori antigen test in stool
排除标准
- •Treatment with proton pump inhibitors, bismuth, H2 receptor antagonist, or sucralfate within the two weeks before study entry, recent use of antibiotics (within one month), allergy to any of the study drugs, active bleeding, gastric surgery, pregnancy, any current malignancy.
研究组 & 干预措施
Naïve patients - ACO therapy
One hundred patients naive to H. Pylori eradication therapy will receive ACO therapy for 14 days (amoxicillin 1 g with breakfast and dinner, clarithromycin 500 mg with breakfast and dinner and lansoprazole 40 mg twice daily before meals).
干预措施: Naïve patients - ACO therapy (Drug)
Naïve patients - LNDL therapy
One hundred patients naive to H. Pylori eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
干预措施: Naïve patients - LNDL therapy (Drug)
Naïve patients - MNDL therapy
One hundred patients naive to H. Pylori eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
干预措施: Naïve patients - MNDL therapy (Drug)
Treatment-experienced patients- LNDL therapy
One hundred patients who were unresponsive to previous eradication therapy will receive LNDL therapy for 14 days (Levofloxacin 750 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
干预措施: Treatment-experienced patients- LNDL therapy (Drug)
Treatment-experienced patients- MNDL therapy
One hundred patients who were unresponsive to previous eradication therapy will receive MNDL therapy for 14 days ( Moxifloxacin 400 mg with breakfast, nitazoxanide 500 mg twice daily with meals, doxycycline 100 mg twice daily and Lansoprazole 40 mg twice daily before meals)
干预措施: Treatment-experienced patients- MNDL therapy (Drug)
结局指标
主要结局
Number of participants with negative results of enzyme immunoassay H. pylori antigen test in stool (Monocent, Inc., CA, USA).
时间窗: 4 weeks after completion of treatment
successful eradication of H. pylori confirmed by H. pylori antigen test in stool. Monocent, Inc.'s H. pylori Antigen Test System is an enzyme immunoassay for the qualitative and quantitative detection of H. pylori antigen in human stool. The patient has to be asked to collect the specimen avoiding any possible contact with urine or water. The patient submitted to the test should not be under antibiotic or anti-acid treatments. immunoassay for the qualitative and quantitative detection of H. li tiihtlIt iitdd id ithiy fthqlitti pylori antigen in human stool. diif iblHli
次要结局
- Number of participants with treatment-related adverse events as assessed by Egyptian pharmacovigilance Center (EPVC) criteria(Through study completion, an average of 24 weeks)
研究者
Gasser Ibrahim El-Azab
Professor of Hepatology and Gastroenterology
National Liver Institute, Egypt