NCT00702026已完成不适用
The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain tolerance threshold
研究概览
简要总结
The purpose of this study is to determine whether a specifically designed multispecies probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and microbiological parameters will be studied.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of IBS according to the Rome III criteria
- •Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg
- •Age between 18 and 65 years
- •BMI between 18.5 and 30 kg/m2
排除标准
- •Known gastro-intestinal diseases
- •Major abdominal surgery
- •Previous radiotherapy, chemotherapy
- •Clinical significant systemic diseases
- •Critically ill patients or patients suffering from severe acute pancreatitis
- •Patients with organs failure
- •Patients receiving enteral feeding
- •Excessive alcohol intake (greater than 15 consumptions per week)
- •(planned) pregnancy or lactation
- •Use of pre-, probiotics in the month before and during the study
- •Use of antibiotics in the two months before and during the study
- •Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study
- •Use of anti depressives (especially SSRI's) in the month before and during the study
- •Use of other medication if less then one month on stable dosage
研究组 & 干预措施
1
Experimental
干预措施: multispecies probiotic (Ecologic 801) (Dietary Supplement)
2
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Pain tolerance threshold
时间窗: t=0 and t=6 weeks
VAS score for pain at pressure step 29 mmHg
时间窗: t=0 and t=6 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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