Impact of Bacillus Clausii Administration on Irritable Bowel Syndrome Patients - a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Symptomatic response
研究概览
简要总结
Probiotics have been proposed as useful therapeutic alternatives for the treatment of irritable bowel syndrome patients. Bacillus clausii is a probiotic that has been used for the treatment of acute diarrhea among adults and pediatric patients, as well as an adjunctive therapy for the treatment for Helicobacter pylori infection. It has been proposed that Bacillus clausii is effective for the treatment of irritable bowel syndrome-related symptoms (especially diarrhea and bloating) in non-controlled trials. The aim of the proposed investigation is to determine whether the administration of Bacillus clausii during two weeks plus dietary advice compared to antispasmodics plus dietary advice would be an effective and safe alternative.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with non-constipated irritable bowel syndrome according to Rome IV criteria
排除标准
- •Allergy to Bacillus clausii spores
- •Prior treatment with antibiotics or probiotics (4 weeks)
- •Not willing to fulfill symptom diary
- •Pregnancy or breastfeeding
- •Clinical suspicion of organic disease
研究组 & 干预措施
Bacillus clausii
Bacillus clausii administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome
干预措施: Bacillus clausii (Drug)
Antispasmodic
Trimebutine administered orally for two weeks plus standard dietary advice for non-constipated irritable bowel syndrome
干预措施: Trimebutine (Drug)
结局指标
主要结局
Symptomatic response
时间窗: After two weeks of treatment
Decrease of at least 50% of symptom severity score - The Irritable Bowel Syndrome Symptom Severity Scale, which consists of five visual analogue scale- questions: their values range from 0 to 100, thus the total score ranges from 0 to 500. Based on previously published studies, clinical response will be defined as a decrease in at least 50% of the initial score
次要结局
- Symptomatic relapse(Four weeks after treatment completion)
研究者
Juan Sebastian Lasa
Clinical Professor
Hospital Britanico