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临床试验/NCT02367612
NCT02367612已完成2 期

Fermented Milk on the Appearance of Common Winter Infectious Diseases

Federico II University4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
140
试验地点
4
主要终点
The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract

研究概览

简要总结

Respiratory and gastrointestinal infections are common in children under the age of 4 years, especially after the start of schooling. These conditions are facilitated by a still incomplete functional maturation of the immune system and the anatomical structure and function of the respiratory and gastrointestinal tract still developing. The frequency and duration of these conditions involves a high discomfort and significant costs, in relation to medical appointments, taking medication, the need for hospitalization, days of absence from school and work days lost by parents. 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, with sometimes conflicting results. Diversity in experimental designs, populations evaluated, and bacterial strains used in the preparation of fermented products are probably responsible for these discrepancies. Recently we started a study approved by the Ethics Committee for Biomedical Activities "Carlo Romano" of the University of Naples "Federico II" (protocol number 210/12) to evaluate the effectiveness of foods fermented with Lactobacillus paracasei CBA-L74 in the prevention of common winter infections in school children aged between 12 and 48 months. Studies of pre-clinical phase showed anti-inflammatory activity of milk fermented with the strain Lactobacillus paracasei L74-CBA in terms of stimulation of the production of the cytokine IL-10 and decreased synthesis of IL-12, also in response to stimulation with Salmonella typhimurium. The data were obtained in in vitro studies on dendritic cells and ex vivo intestinal biopsies as well as in tests on healthy mice and on a mouse model of experimental colitis. A preliminary analysis of the data was found that subjects treated with fermented milk showed fewer infectious episodes, as well as a lower incidence of respiratory tract infections or gastrointestinal, with a statistically significant difference between the study groups. It was also observed a significant increase in the levels of α- and β- defensins, LL-37 and secretory IgA in the group of subjects treated with fermented milk compared to subjects treated with fermented rice or placebo.

Therefore, we decided to extend the period of study of five additional months, in order to perform an evaluation of the effectiveness of fermented milk (which was more effective)vs placebo.

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)

入排标准

年龄范围
12 Months 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 12-48 months attending educational program (either at nursery or primary school)

排除标准

  • concomitant chronic/congenital diseases and disabilities
  • active tubercolosis
  • congenital cardiac defects
  • autoimmune diseases
  • immunodeficiency
  • cystic fibrosis
  • metabolic diseases
  • malignancy
  • .chronic pulmonary diseases
  • malformation of he GI tract
  • food allergy
  • antibiotic use
  • pre/pro/symbiotic use
  • severe wasting (less than 3 standard deviations of weight-for-height z score)

结局指标

主要结局

The occurrence of common winter infectious diseases involving respiratory and/or gastrointestinal tract

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto Berni Canani

MD, PhD

Federico II University

研究点 (4)

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