Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Colony forming units of feces (CFU/g)
研究概览
简要总结
This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. The hypothesis is that L. reuteri from TEST#1 will demonstrate an improved survival in the GIT of toddlers compared to that of TEST#2.
This study is a single-centre, randomized, double-blind, comparator-controlled, parallel group study. The study will be conducted at the Clinical Innovation Lab (CIL) at Nestlé Research.
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
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 24 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is between 24 months to 36 months of age.
- •Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
- •Healthy status based on medical history and physical examination
- •Weight- for-age and height-for-age within normal range on local childhood growth chart.
- •Written informed consent are obtained from both parents/legally authorized representative (LAR).
- •Parents/legally authorized representative must be able to provide evidence of the parental authority and identity.
- •Parents /legally authorized representative are of legal age of consent and must understand the informed consent and other study documents.
- •Parents/legally authorized representative are willing and able to fulfill the requirements of the study protocol.
排除标准
- •Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
- •Prior to study participation, child has shown limited or no interest in drinking toddler milk.
- •Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
- •Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
- •Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
- •Child is currently consuming or has consumed any formulas or taking any supplement containing GOS within the past 48 hrs prior to product in take, and who are not willing accept a temporary cessation of the consumption during the study period.
- •Child is currently participating in another investigational clinical trial.
- •Family or hierarchical relationships with the CIL team.
结局指标
主要结局
Colony forming units of feces (CFU/g)
时间窗: Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21
The primary end point is quantification of L. reuteri DSM 17938 in stool using quantitative polymerase chain reaction (qPCR).
次要结局
- Safety and tolerability(Between Day 0 and Day 21)
- Gut microbiota(Between Day 0 and Day 21)
- Gastrointestinal (GI) tolerance and stooling patterns(Between Day 0 and Day 21)
- Assessment of dietary variety(Between Day 0 and Day 21)