Observational, Prospective, Multicentric Study of the Effect of Bifidobacterium Longum 35624 on Quality of Life of Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biocodex
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
研究概览
简要总结
The main objective of this observatory is to evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity
详细描述
This observatory evaluate the effect of Bifidobacterium longum 35624 on the quality of life of IBS patients having different subtypes of transit pattern and different level of symptom severity, after a one-month treatment with Bibidobacterium longum 35624, 1x10^9 CFU/capsule, 1 capsule/day.
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
- •Male or female, at least 18 years of age
- •Gastroenterology consultation for an Irritable Bowel Syndrome according to Rome IV criteria
- •Having received a first prescription of Bifidobacterium longum 35624 during the consultation (independently of participation in the observatory)
- •Informed and having declared his/her non-opposition to the study.
排除标准
- •Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook
- •Having already taken Bifidobacterium longum 35624
- •Having received probiotics or antibiotics within 2 weeks previous
- •Having started within the last 7 days a treatment that can interfere with the investigator's evaluation of the investigational product under investigation
- •Participant in another trial
- •Pregnant or breastfeeding women
- •Being under guardianship or curator.
- •Not having a good enough command of reading and comprehension of the French language to correctly complete the questionnaires and the notebook
结局指标
主要结局
Quality of life assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).
时间窗: Assessed at baseline and after 1 month of treatment
Change from baseline of quality of life as assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL, scoring from 0 to 100, with higher scores indicating better IBS specific quality of life) in IBS patients having different subtypes of transit pattern and different level of symptom severity.
次要结局
- Change of Stool consistency(Assessed at baseline, day10, day 20 and day 30)
- IBS Symptom Severity(Assessed at baseline and after 1 month of treatment)
- Quality of life subscores assessed with the Irritable Bowel Syndrome Quality Of Life questionnaire (IBS-QOL).(Assessed at baseline and after 1 month of treatment)
- Patient satisfaction(Assessed after 1 month of treatment)
- Compliance to the treatment(Assessed after 1 month of treatment)
- Patient's overall impression after treatment(Assessed after 1 month of treatment)
- Physician's satisfaction(Assessed after 1 month of treatment)