EUCTR2018-001355-12-IT进行中（未招募）1 期
Phase IV, randomized, double-blind, multicenter, placebo-controlled clinical trial to evaluate the efficacy and the safety of enterogermina (Bacillus clausii) in treating patients with small intestinal bacterial overgrowth - BASTA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male and female patients aged >/=18 years.
- •- Small intestinal bacterial overgrowth diagnosed based on positive hydrogen breath test (GBT or LBT) as described in The North American Consensus within 2 weeks prior to study entry.
- •- Patients reporting recurrent bloating or feeling of abdominal distension, defined as recurrent feeling of bloating or visible distension at least 3 days/month in the last month.
- •- Patients presenting abnormal stool frequency (abnormal is defined as >3 bowel movements/day and <3 bowel movements/week) and/or abnormal stool form (lumpy/hard or loose/watery stool) as per the Bristol-Stool scale.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 214
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- History of intestinal surgery (except cholecystectomy and appendectomy).
- •- Use of antibiotic or probiotics (medications or dietetic supplements) in the last month prior to study entry.
- •- Standard medication consisting of laxative or antidiarrheal.
- •- Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania, or major psychiatric illnesses needing pharmacological treatment. Well-compensated depression does not exclude a potential patient.
- •- Patients not able to maintain their usual diet and lifestyle during the course of the study.
研究者
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