Probiotics for Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Adequate relief
研究概览
简要总结
The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months.
By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters.
The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule.
The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.
详细描述
Background: In management of IBS, no treatments have showed great efficacy. IBS is a non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a dietary supplement and have no adverse effects. In some studies it has shown beneficial effect on some of the IBS patients symptoms, but some of the results are questionable. The studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill ROME III criteria
- •age 18-50 years
- •signed informed content
排除标准
- •Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
- •abnormal physical examination
- •comorbidity
- •lacking ability to talk and understand danish
- •pregnancy
- •For patients > 40 years. Changed bowel habits, with duration > 3 weeks, but < 1 year
研究组 & 干预措施
Placebo
Capsules containing maltodextrin.
干预措施: Placebo (Dietary Supplement)
Probiotics
Probiotics containing the 3 strains: Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12 in the dose of 2 x 109 - 10 x 109 CFU/capsule. The patients are to take 2x2 capsules a day.
干预措施: Probiotics (Dietary Supplement)
结局指标
主要结局
Adequate relief
时间窗: Every month for 12 months
The patients are asked "In the last seven days, have you had adequate relief of your IBS symptoms?" . They are asked this question every month ( in a monthly letter) for 12 months.
次要结局
- gastrointestinal symptoms(Every month for 12 months)
研究者
Luise Molenberg Begtrup
Doctor
University of Southern Denmark