Effects of Cultura Yoghurt on Symptoms Intestinal Flora and Immunological Changes in Patients With Irritable Bowel Syndrome(IBS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Relief of IBS symptoms
研究概览
简要总结
To determine the effect of cultura probiotic yoghurt on number of responders to treatment during 8 weeks of treatment in comparison to placebo. To determine the effect of cultura yoghurt on change in total score of (IBS) irritable bowel syndrome severity index during 8 weeks of treatment in comparison to placebo in IBS out patients.
详细描述
Recent research has shown taht probiotic may give positive effect on symptoms among patients with (IBS) Irritable Bowel Syndrome. The mechanism behind the positive effect are not known but a positive effect on different cytokines are a possible mechanism. Also effect on the large intestine bacterial mass could be of importance.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed consent to participate age 18-70 years IBS according to Rome II criteria
排除标准
- •Participation in a clinical study one month prior to screening visit and throughout the study.
- •Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
- •Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the investigator.
- •Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
- •Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the investigator.
- •Severe psychiatric disease as judged by the investigator.
- •Previous history of drug or alcohol abuse six months prior to screening.
- •Intolerance or allergy against milk products or gluten.
- •Use of other probiotic products (according to sponsor's list) 2 weeks prior to the study and throughout the study.
- •Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
- •Consumption of cortisone, NSAID or other anti-inflammatory drugs on a regular basis 2 weeks prior to screening and throughout the study.
- •Pregnant or lactating or wish to become pregnant during the period of the study.
- •Lack of suitability for participation in the study for any reason as judged by the investigator.
结局指标
主要结局
Relief of IBS symptoms
时间窗: 6 weeks intervention and 6 weeks follow up
The primary endpoint of this study was the proportions of patients reporting adequate relief of their IBS symptoms at least 50 % of the weeks during the treatment period
次要结局
- Effects on gastrointestinal and extraintestinal symptoms(September 2005 to May 2006)