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临床试验/NCT01901380
NCT01901380已完成不适用

Effect of Lactobacillus GG on the Appearance of Functional Gastrointestinal Disorders in Children With Cow's Milk Allergy

Federico II University1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
1
主要终点
Appearance of functional gastrointestinal disorders

研究概览

简要总结

Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. It has been demonstrated that it could be a risk factor for the development of the functional gastrointestinal disorders in children. Intestinal microflora has been indicated as potential target for the management of CMA and FGDIs through the use of probiotics. Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following the addition of LGG, satisfying both the American Academy of Pediatrics guidelines. Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and exerted at different levels: epithelium, immune system and enteric nervous system. Studies and meta-analyses showed that LGG increases treatment success in children with functional gastrointestinal disorders.

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
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children (aged from 4 to 6 yrs) with a history of sure diagnosis of cow's milk allergy obtained in the first year of life treated with hypoallergenic formula

排除标准

  • Age higher than 12 months,
  • concomitant chronic systemic diseases,
  • congenital cardiac defects,
  • active tuberculosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • malignancy,
  • chronic pulmonary diseases,
  • malformations of the gastrointestinal tract,
  • suspected eosinophilic esophagitis or eosinophilic enterocolitis,
  • suspected food-protein-induced enterocolitis syndrome,
  • suspected cow's milk proteins-induced anaphylaxis.

结局指标

主要结局

Appearance of functional gastrointestinal disorders

时间窗: functional gastrointestinal disorders

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 (1)

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