Fiber Tolerability In Children Aged 3-7 Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale
研究概览
简要总结
Determination of the digestive tolerability of the PROMITOR® in children from 3 to 7 years old.
详细描述
The aim of the trial is to determine, using a dose escalation design, the digestive tolerability of the PROMITOR®given at the doses of 6, then 9 and finally 12 g (corresponding to 4, 6, and 8 g of fibers respectively) twice a day with the meals of the morning and of the evening versus control (maltodextrin, no fiber) over one week of intake in children from 3 to 7 years old.
As it is an exploratory study there is no categorization between primary and secondary objectives.
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
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children
- •Aged between 3 and 7 years old
- •Acceptance of the taste of the product
- •Having breakfast on daily basis
- •Consent and/or assent received according to regulation
- •Informed consent of both parents/guardians (in respect with the French regulation)
- •Parents/guardians affiliated to a health insurance (in respect with the French regulation)
排除标准
- •Specific food regimen
- •Intolerability or food allergy
- •Antibiotic or any medication impacting the gut transit during the 2 weeks before the study
- •Chronic gastrointestinal disease
- •Gastroenteritis in the 2 weeks preceding the study
- •Constipation or diarrhea based on ROMEIII criteria (in average: more than 3 stools per day or less than 3 stools per week)
- •Children and parents expected not to understand and perform the trial correctly (i.e.: troubles in learning and/or speaking)
- •Child in a situation which, in the opinion of the principal investigator, could interfere with the optimal participation to the study or constitute a particular risk of non-compliance
- •Having participated in another clinical trial for 1 month, or currently participating in a clinical trial
- •Under legal protection or deprived from his rights following administrative or judicial decision (in respect with the French regulation)
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (including Maltodextrin) (Drug)
Dose 1 - Promitor®
Investigational product Dose 1
干预措施: Dose 1 - Promitor® (Drug)
Dose 2 - Promitor®
Investigational product Dose 2
干预措施: Dose 2 - Promitor® (Drug)
Dose 3 - Promitor®
Investigational product Dose 3
干预措施: Dose 3 - Promitor® (Drug)
结局指标
主要结局
Assessment of the digestive tolerability of the Investigational Product (abdominal pain) using analog visual scale
时间窗: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (bloating) using analog visual scale
时间窗: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (rumbling) using analog visual scale
时间窗: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (stools consistency & frequency) using analog visual scale
时间窗: 7 days of intake
Using analog visual scale
Assessment of the digestive tolerability of the Investigational Product (flatulence) using analog visual scale
时间窗: 7 days of intake
Using analog visual scale
次要结局
未报告次要终点