Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Fructans on Bowel Habits of Constipated Young Children One to Three Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stool consistency
研究概览
简要总结
The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.
详细描述
The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children. It is a double-blind, randomized, placebo-controlled trial.This study plans to recruit into the group of 100 participants (at least 80 of them completed) in 2018-2020.The two groups for the study are product group (prebiotic fructans) and control group (placebo maltodextrin).Duration of intervention is 6 weeks, including 2 weeks for run-in and 4 weeks for intervention.Efficacy parameters are stool consistency (assessed with Amsterdam infant stool scale),stool frequency, stool amount and stool color (assessed with Amsterdam infant stool scale, treatment success, tolerance and acceptability).
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
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of functional constipation following ROME4 criteria.
- •Subject is otherwise healthy at the time of pre-examination.
- •Subject is aged 1-3 years at the time of pre-examination.
- •Subject and caretaker are able and willing to follow the study instructions.
- •Subject is suitable for participation in the study according to the investigator/physician/study personnel.
- •Written informed consent is given by parent or legal guardian.
排除标准
- •No legal guardian's command of any local language.
- •Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
- •Other metabolic or renal abnormalities or mental retardation (Child's mental delay).
- •Food allergies or intolerances.
- •Using drugs (e.g. antibiotics) influencing gastrointestinal function (4 weeks before run-in, 6 weeks before intervention).
- •Use of laxatives and labelled pre- and probiotics in the previous 2 weeks before the beginning of run-in (4 weeks before intervention)
- •Subjects who are currently involved or will be involved in another clinical or food study
研究组 & 干预措施
Prebiotic fructans
Prebiotic fructans. Prebiotic will be mixed into foods or drinks and consumed twice daily.
干预措施: Prebiotic fructans (Dietary Supplement)
Maltodextrin
Maltodextrin. Maltodextrin will be mixed into foods or drinks and consumed twice daily.
干预措施: Non-prebiotic maltodextrin (Dietary Supplement)
结局指标
主要结局
Stool consistency
时间窗: 4 weeks
Assessed by the parents in a continuous daily bowel diary over the study period using the Amsterdam Infant Stool Scale (AISS) comprised of a 4-point scale (A: watery, B: soft, C: formed, D: hard)
次要结局
- Stool amount and stool colour(4 weeks)
- Treatment success(4 weeks)
- Faecal microbiota(4 weeks)
- Stool frequency(4 weeks)
- Faecal Short Chain Fatty Acids concentration(4 weeks)
- Faecal pH(4 weeks)