Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Stool consistency
研究概览
简要总结
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.
详细描述
The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is healthy at the time of pre-examination
- •Child was born on term or preterm (≥ 32 weeks of gestation)
- •Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
- •Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)
- •Child receives at least one meal per day as complementary feeding
- •Child and legal guardian are able and willing to follow the study instructions
- •Child 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 psychomotor retardation (e.g. hypotonia)
- •Child has allergy to cow's milk protein or lactose intolerance
- •Child has been or is currently breast-fed more than once daily (6 weeks before intervention)
- •Child has mostly loose or watery stools in ≥ 50% of defecations
- •Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
- •Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention
- •Child is currently involved or will be involved in another clinical or food study
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
次要结局
- Stool amount(4 weeks)
- Sleep(4 weeks)
- Stool colour(4 weeks)
- Body weight(4 weeks)
- Body height(4 weeks)
- Faecal Microbiota(4 weeks)
- Stool frequency(4 weeks)
- Tolerance and acceptability(4 weeks)
- Stool pH(4 weeks)
- stool short-chain fatty acids(4 weeks)