NCT01658852撤回3 期
Effects and Safety of Metronidazole in Patients With Gastrectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Patient's Global Assessment of abdominal symptom
研究概览
简要总结
Recent study showed that SIBO is common among postgastrectomy patients and It appears to be associated with postprandial intestinal symptoms and might aggravate late hypoglycemia. SIBO could be a new therapeutic target for managing intestinal symptoms in postgastrectomy patients.The purpose of this study is to determine whether antiboitic (metronidazole) is effective in patients with postgasrectomy syndrome
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •age between 18 and 70
- •gastrectomy for early gastric cancer with complete resection
- •no reccurrence after follow up more than 6 months
- •identified small bowel bacterial overgrowth by hydrogen breath test
- •symptoms of postgastrectomy syndrome
排除标准
- •hypersensive to metronidazole
- •systemic chemotherapy history
- •other organic gastrointestinal disease (inflammatory bowel disease, carcinoid syndrome, amyloidosis, intestinal obstruction)
- •other gastrointestinal operation history except appendectomy, cholecystectomy)
- •recent colonoscopic examination (within 30 days)
- •uncontrolled psychopathy
- •drug or alcohol abuser
- •pregnant or breast feeding woman
- •recent history of antibiotics treatment (within 90 days)
- •recent history of PPI or H2 blocker treatment (within 30 dyas)
- •recent history of probiotics treatment (within 30 dyas)
- •recent history of prokinetics or antispasmotic treatment (within 15 days)
- •severe systemic illness
研究组 & 干预措施
Metronidazole
Active Comparator
active drug: metronidazole 500mg three time per day for 10 days
干预措施: metronidazole (Drug)
Placebo
Placebo Comparator
Placebo three times per day for 10days
干预措施: Placebo (Drug)
结局指标
主要结局
Patient's Global Assessment of abdominal symptom
时间窗: 4 week
次要结局
未报告次要终点
研究者
Myung-gui Choi
prof.
The Catholic University of Korea
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