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临床试验/NCT04750980
NCT04750980已完成不适用

Microbiota as Potential Target for Innovative Preventive and Therapeutic Strategies for Food Allergy

Federico II University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Evaluation of gut microbiome features in allergic children and in healthy controls.

研究概览

简要总结

Food allergy derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for gut microbiota in oral tolerance development. An altered composition of gut microbiota results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. Preliminary results of MATFA study demonstrated gut microbiota in allergic children.These findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
48 Months 至 84 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children with sure diagnosis of food allergy,
  • children with sure diagnosis of respiratory allergy

排除标准

  • age at enrollment <48 months or >84 months;
  • eosinophilic disorders of the gastrointestinal tract;
  • chronic systemic diseases;
  • congenital cardiac defects;
  • acute or chronic infections;
  • autoimmune diseases;
  • immunodeficiencies;
  • chronic inflammatory bowel diseases;
  • celiac disease;
  • cystic fibrosis or other forms of primary pancreatic insufficiency;
  • genetic and metabolic diseases;
  • food intolerances;
  • malignancy;
  • chronic pulmonary diseases;
  • malformations of the respiratory tract or of the gastrointestinal tract;
  • pre-, pro- or sinbiotic use in the previous 3 months;
  • antibiotics or gastric acidity inhibitors use in the previous 3 months.

结局指标

主要结局

Evaluation of gut microbiome features in allergic children and in healthy controls.

时间窗: at enrollment

Comparatively evaluation of gut microbiome features in allegic children and in healthy controls.

次要结局

  • Evaluation of gut microbiome features in children affected by different type of food allergy(at enrollment)
  • Gut microbiome and allergy disease course(at enrollment)
  • Evaluation of gut microbiome features in children affected by different allergies (food and respiratory)(at enrollment)

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

Associate Professor

Federico II University

研究点 (1)

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