NCT01001949已完成不适用
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
Fugeia NV2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Bifidobacteria content in feces
研究概览
简要总结
The investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).
The objective of this study is to analyze the effect of the intake of WBE on various parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was analyzed using treatment emergent Adverse Events (AEs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •regular eating habits
- •consent to take in the study product according to the study protocol
- •consent of parents for follow-up of the protocol
- •subject is willing to maintain his/her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
排除标准
- •low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
- •recent use of antibiotics
- •abdominal surgery in the past
- •use of medication or dietary supplements known to influence gastrointestinal tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti-diarrhea medication and/or probiotic medication
- •serious illness within 3 months of start of clinical trial
- •chronic gastrointestinal conditions such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
- •complete anesthetics within 3 month of the start of the clinical trial
- •allergy for wheat products
- •celiac disease
- •Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk
结局指标
主要结局
Bifidobacteria content in feces
时间窗: day 19 or 20 of each intervention period
butyric acid content in feces
时间窗: day 19 or 20 of each intervention period
stool frequency
时间窗: third week of each intervention period
次要结局
- adverse events(whole study period)
研究者
研究点 (2)
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