Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The improvement of IBS symptoms
研究概览
简要总结
Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.
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
- Double (Participant, Investigator)
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
- •age: 18~65 years
- •diarrhea type irritable bowel syndrome (by ROME III criteria)
- •no organic bowel disease (by colonoscopy or barium enema)
排除标准
- •pregnant women or nursing mothers
- •hypersensitivity to probiotics
- •congestive heart failure or ischemic heart disease
- •systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg
- •uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism
- •abdominal surgery (exception: appendectomy, hernia surgery)
- •more than moderate alcohol drinking
结局指标
主要结局
The improvement of IBS symptoms
时间窗: 6 weeks (symptom diary and weekly questionnaire)
IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7).
次要结局
- Changes in fecal microflora(baseline and after 6weeks)
- Changes of biochemical marker(baseline and after 6weeks)