EUCTR2006-000500-16-DE进行中（未招募）不适用
E. coli Stamm Nissle 1917 zur Behandlung des postinfektiösen/Antibiotika-assoziierten Reizdarmsyndroms mit Diarrhö E. coli strain Nissle 1917 for the treatment of post-infectious/antibiotic-associated irritable bowel syndrome with diarrhea - Mut-IBS-Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 208
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
- •- age between 18 and 55 years
- •- signed informed consent form by the patient
- •- fulfilling the ROME-III-criteria
- •- IBS with diarrhea
- •- post-infectious/antibiotic-associated IBS
- •- flexible sigmoidoscopy or colonoscopy within the past 5 years
- •- sonography of the abdomen within the past 5 years
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •General exclusion criteria:
- •- participation in a clinical trial within the past 30 days
- •- simultaneous participation in another clinical trial
- •- insufficient contraception in women of childbearing age
- •- pregnancy and/or nursing period
- •- insufficient cooperativeness of the patient
- •- limited legal competence of the patient
- •- alcohol or drug abuse
- •- known hypersensitivity against any of the components of the trial medication
- •Anamnestic exclusion criteria:
- •- absence of current IBS-symptoms
- •- infectious diarrhea
- •- functional diarrhea
- •- inflammatory bowel disease
- •- known diverticular disease
- •- known celiac disease
- •- known lactose intolerance
- •- major surgeries on the colon
- •- clinically relevant gastrointestinal stenoses
- •- anamnestic data indicating an organic disease (red flags”)
- •- administration of anti-depressants
- •- administration of E. coli strain Nissle 1917 within the past 3 months
- •- serious concomitant diseases of
- •- reasons which in the investigator’s judgment argue against inclusion of the patient
研究者
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