Use of Rifaximin in Patients With Functional Dyspepsia: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Adequate relief of dyspeptic symptoms at end of treatment
研究概览
简要总结
Functional dyspepsia is a very common medical condition, which occurs in up to 30% of people in the community. However, results of current pharmacological treatment on functional dyspepsia are unsatisfactory. Rifaximin is a minimally absorbed antibiotic that has been used in treatment of non-constipated irritable bowel syndrome (IBS). In particular, bloating and abdominal pain was improved by rifaximin treatment in this group of IBS patients. Whilst there is considerable overlap in symptoms of functional dyspepsia and IBS, the investigators test whether rifaximin is also effective in curing post-prandial distress symptoms related to dyspepsia.
详细描述
The aim of this study is to test the effects of rifaximin, a minimally absorbed antibiotics, on symptoms of patients with functional dyspepsia.
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
- •Non-ulcer dyspeptic patients who fulfill post-prandial distress syndrome according to the Rome III Criteria
- •Active dyspeptic symptom
- •Normal upper endoscopy
- •Urea Breath Test -ve or Rapid urease test -ve
- •Not typical gastroesophageal reflux or biliary colic symptoms, but presence of infrequent acid reflux is allowed
排除标准
- •No active dyspeptic symptom
- •Allergic to rifaximin
- •Recent antibiotics use in the past 8 wk
- •Recent PPI or H2RA in past 4 wk
- •On anti-coagulants, anti-convulsant or oral contraceptives
- •On NSAIDs, aspirin or Clopidogrel
- •Pregnancy or breast feeding
- •Previous gastric surgery
研究组 & 干预措施
Rifaximin
干预措施: Rifaximin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adequate relief of dyspeptic symptoms at end of treatment
时间窗: end of treatment (week 2)
global symptom improvement
次要结局
- Individual dyspeptic symptom scores(week 2, 4 and 8)
研究者
LEUNG Wai Keung
Clinical Professor
The University of Hong Kong