Efficacy of A 2'-Fucosylactose-based Food Supplement on the Prevention of Respiratory and Gastrointestinal Infections in Schhol-attended Children: a Randomized, Double-blind, Placebo-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary outcome
研究概览
简要总结
Respiratory and gastrointestinal infections are frequent problems in children under 4 years of age, especially after the start of schooling. These conditions are facilitated by an incomplete maturation of the immune system and by the anatomical and functional structure of the respiratory and gastrointestinal tract still in development.
Functional foods derived from the fermentation of cow's milk with probiotic strains have been proposed for the prevention of infectious diseases in children. Several products have been investigated, sometimes with conflicting results. Some scientific evidence has shown that the administration of Vitamin D, Zinc, Beta glucan, 2'-Fucosyllactose can stimulate the immune defenses and reduce the number and severity of infectious episodes. In particular, 2'-fucosyllactose is one of the oligosaccharides of breast milk. It has both a prebiotic and immunoregulatory action since it is able to prevent the adhesion of pathogens to epithelial surfaces and subsequent translocation.
Healthy school-going children aged between 12 and 48 months, who attend school at least 5 days a week, will be evaluated.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Nobody knows the randomization code
入排标准
- 年龄范围
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy school-going children aged 12 to 48 months who attend school at least 5 days a week
排除标准
- •Age less than 12 months and more than 48 months;
- •Concomitant presence of chronic diseases
- •Congenital heart disease;
- •Tuberculosis;
- •Functional gastrointestinal disorders;
- •Gastrointestinal or urinary surgery of the respiratory tract;
- •Autoimmune diseases;
- •Immunodeficiencies;
- •Chronic inflammatory bowel diseases;
- •Celiac disease;
- •Cystic fibrosis;
- •Metabolic diseases;
- •Lactose intolerance;
- •Chronic lung diseases and malformations of the gastrointestinal tract;
- •Food allergies;
- •Eosinophilic esophagitis;
- •Other hypereosinophilic diseases of the gastrointestinal tract;
- •Diarrhea at enrollment;
- •Severe malnutrition (z score for weight/height less than 3SD);
- •Taking antibiotics and/or pre/pro/symbiotics/immunostimulants within 2 weeks of starting the study;
- •Breastfeeding in progress
结局指标
主要结局
Primary outcome
时间窗: The dietary supplement and placebo will be administered for three months from the date of enrollment.
The primary aim of the study will be the percentage of children who will present at least one infectious episode (acute gastroenteritis, rhinitis, otitis, pharyngitis, laryngitis, tracheitis) diagnosed by the pediatrician during the 3-month study period.
次要结局
未报告次要终点
研究者
Ruggiero Francavilla
Professor
University of Bari