A Double Blind Randomized Study for Treatment of Helicobacter Pylori Infection: 14-day Non-bismuth Quadruple Therapy Versus Triple Therapy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- HP eradiction rate
研究概览
简要总结
In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.
详细描述
This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.
The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.
H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.
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, Investigator)
盲法说明
a placebo which has the same visual characteristics as metronidazole in the boxes of the triple therapy
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18 and 65, with documented Hp infection.
排除标准
- •are excluded patients:
- •With Cirrhosis.
- •With Renal failure (serum creatinine> 120 µmol / L).
- •Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
- •Having severe psychiatric disorders.
- •Having had gastric surgery in their history.
- •Having already received an HP eradication treatment.
- •Having received an antibiotic within the last two weeks.
- •Who are allergic to one of the antibiotics used in the anti-Hp cure.
- •Who are drug addicted.
研究组 & 干预措施
concomitant quadruple therapy (QC)
PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days
干预措施: metronidazole based quadriple therapy (Drug)
triple therapy (TT)
PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) AND PLACEBO for 14 days.
干预措施: placebo based quadriple therapy (Drug)
结局指标
主要结局
HP eradiction rate
时间窗: 6 weeks after completion of study treatment
assessment by breath test
次要结局
- percentage of adverse reactions(3 months)
研究者
mohamed bouchoucha
Assistant Clinical Data management
Les Laboratoires des Médicaments Stériles