Efficacy and Safety of Alflorex® Bei Reizdarm, a Probiotic Containing Bifidobacterium Longum 35624®, in Patients With Irritable Bowel Syndrome in Medical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Relative change in overall IBS symptoms compared to day 1 (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea symptom scores)
研究概览
简要总结
This Post-Market Clinical-Follow Up (PMCF) study gains data on the efficacy and safety of "Alflorex bei Reizdarm", a probiotic based on Bifidobacterium longum 35624, in the daily use by irritable bowel syndrome (IBS) patients. The aim of this study is the observation of the influence of "Alflorex bei Reizdarm" on typical symptoms, severity score and quality of life of IBS patients in medical practice and everyday use.
详细描述
This Post-Market Clinical-Follow Up (PMCF) study observes adult patients with irritable bowel syndrome (IBS) which receive "Alflorex bei Reizdarm", a probiotic based on Bifidobacterium longum 35624, for 8 weeks by recommendation of their physician. IBS symptoms are recorded on a weekly basis by the participants. IBS severity score, interference with general life and safety parameters are also recorded. Primary objective is the assessment of the change in overall IBS symptoms (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, diagnosed IBS patients with typical IBS symptoms (abdominal pain, bloating, gas, constipation or diarrhea) and physician's recommendation to take the study medication (probiotic with B. longum 35624) for 8 weeks
排除标准
- 未提供
结局指标
主要结局
Relative change in overall IBS symptoms compared to day 1 (sum of abdominal pain, bloating, gas, difficulty in defecating/constipation and urgency/diarrhoea symptom scores)
时间窗: assessed weekly over 8 weeks (from day 1 to day 57)
rated by participant on a 6-point Likert scale (from 0 "no symptoms" to 5 "very severe")
次要结局
- Efficacy & tolerability by participant(assessed at day 57)
- Relative change in the individual IBS symptoms abdominal pain, gas, bloating, difficulty in defecating/constipation and urgency/diarrhoea compared to day 1(assessed weekly over 8 weeks (from day 1 to day 57))
- Severity score of irritable bowel syndrome compared to day 1(assessed at day 1, day 29 and day 57)
- Efficacy & tolerability by physician(assessed at day 57)
- Interference of IBS symptoms with general life(assessed at day 1, day 29 and day 57)