NCT01887483终止4 期
A Double-Blind Placebo-Controlled Randomized Clinical Trial Assessing the Effect of 2 Month Consumption of Vetal Laban Including L. Acidophilus on Functional Gastrointestinal Symptoms Among Subjects Fulfilling Rome III Criteria for IBS
Danisco2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- change in functional bowel symptoms
研究概览
简要总结
A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Males and females aged 18 to 65 years
- •Subjects fulfilling Rome III criteria for IBS
- •Sufficient health and orientation for participating in the trial
- •Obtained his/her informed consent after verbal and written information.
- •Have a high probability for compliance with and completion of the study.
- •Body Mass Index (BMI) between 19 and 35.
排除标准
- •Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, Crohn's disease, celiac disease, major bowel surgery, recurrent diverticulitis) or severely impaired general health including cancer and cancer therapy.
- •Lactose intolerance
- •Unwillingness to refrain from probiotic use during the trial
- •Use of antibiotics within the 3 preceding months prior to recruitment
- •Pregnant, planning pregnancy or lactating
- •Expected major lifestyle changes related to nutrition, exercise, travelling etc.
- •Participation in a clinical trial with an investigational product or drug within 3 months prior to screening.
- •Substance abuse
- •Subjects unable to read and understand the questionnaires
结局指标
主要结局
change in functional bowel symptoms
时间窗: week 0, 4, 8, 12 and 16
Validated questionnaire
次要结局
- change in adequate relief of bowel symptoms(weekly from week 4 to week 12)
- change in stool defecation frequency(week 0, 4, 8, 12 and 16)
- change in stool microbiota(week 4, 8, 12 and 16)
- change in prevalence of adverse events(continuous from week 0 to 16)
- change in stool consistency(week 0, 4, 8, 12 and 16)
研究者
研究点 (2)
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