A Randomized, Double-blinded, Parallel, Placebo-controlled Study to Investigate the Efficacy of Lb Paracasei [Junlebao Lp. N1115] as a Probiotic to Enhance Gut Development in Young Children
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Defecation improvement
研究概览
简要总结
The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to 3 years by the way of a randomised, double-blinded, parallel, placebo-controlled clinical trial, and to explore the change of intestinal microbiota composition and healthy condition after intervention.
详细描述
N1115 Probiotic Supplement contains Lactobacillus paracasei N1115 [Junlebao Lp. N1115], a lactobacillus bacteria strain isolated from traditional homemade yogurt in North China. In recent studys feeding Junlebao Lp. N1115 to C57BL/6 mice, the data suggest that Lp. N1115 enhances intestinal development in neonatal mice, and may confer benefits on the growth at early stage of life.
This study is to investigate if a N1115 Probiotic Supplement product containing Lp. N1115 will improve intestinal health in young children. This randomised, double-blinded, placebo-controlled trial includes two treatment groups which respectively need to recruit 30 volunteers born by cesarean section and aged from 6 months to 3 years. The study group receives N1115 Probiotic Supplement, while the control group receives placebo. The trial lasts for 8 weeks and include four time points of data collection. The stool consistency of children will be recorded everyday, the saliva and stool samples will be collected and analysed.
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 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged ≥ 6 months and ≤ 3 years,
- •Child was born by caesarean section,
- •Parent/Guardian has given written informed consent,
- •Be in generally good health as determined by the investigator.
排除标准
- •Are currently taking probiotics or prebiotics, or have taken them in the past 2 weeks,
- •Unwilling to avoid probiotics/prebiotics for the duration of the study,
- •Has any food allergies or an allergy or hypersensitivity to any component of the study products, including, milk proteins allergy or cow's milk allergy,
- •Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study),
- •Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results,
- •Subjects have taken antibiotics within the past 3 months (history of antibiotic use in previous 6 months recorded),
- •Subjects may not be receiving treatment involving experimental drugs,
- •If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
- •Subjects may not be receiving treatment involving experimental drugs,
- •Exposure to any non-registered drug product within 30 days prior to screening visit.
研究组 & 干预措施
N1115 Probiotic Supplement
A probiotic supplement containing Lactobacillus paracasei N1115 [Junlebao Lp. N1115] Participators, who met inclusion criteria, will receive following product during 8 weeks: N1115 Probiotic Supplement in the form of powder packaged in sachet (one sachet containing 10^9 CFU Lp. N1115).
干预措施: N1115 Probiotic Supplement (Dietary Supplement)
Placebo control
Dietary Supplement: Placebo Participators, who met inclusion criteria, will receive an identical N1115 Probiotic Supplement looking and tasting placebo.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Defecation improvement
时间窗: 8 weeks
Compare the defecation condition of child both in intervention group and placebo group by the way of recording the questionnaire each day. Record number of defecation and type of stool based on Bristol Stool Scale.
GI symptoms
时间窗: 8 weeks
Compare the gastrointestinal symptoms of child both in intervention group and placebo group by the way of recording the questionnaire each day. Record number of flatulence, bloating, cramps and diarrhea compared between child in intervention group and placebo group.
次要结局
- Fecal microbiota(study week 0, 4 and 8)
- Salivary cortisol(study week 0, 4 and 8)