跳至主要内容
临床试验/NCT03863418
NCT03863418已完成不适用

The Use of Probiotic Lactobacillus Rhamnosus GG for Treatment of Atopic Dermatitis in Children

Federico II University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Reduction of SCORing Atopic Dermatitis (SCORAD)

研究概览

简要总结

Atopic dermatitis (AD) is a multifactorial, chronic inflammatory skin disorder that results in areas of dry, itchy skin. AD affects up to 20% of children in Western societies and represents a prevalent, burdensome, and psychologically important pediatric concern.

It often appears in infancy and may persist into adolescence and adulthood. This complex disease is typified by defective skin barrier function with activation of abnormal immunological and inflammatory pathways upon exposure to ubiquitous environmental allergens.

It often appears in infancy and may persist into adolescence and adulthood. This complex disease is typified by defective skin barrier function with activation of abnormal immunological and inflammatory pathways upon exposure to ubiquitous environmental allergens.

This complex disease is typified by defective skin barrier function with activation of abnormal immunological and inflammatory pathways upon exposure to ubiquitous environmental allergens. This phenomenon may be primarily related to mutations in important barrier proteins, in the same fashion as filaggrin in the atopic skin, or may be secondary, reflecting the intestinal mucosal damage caused by local hypersensitivity reactions to food antigens or to microbial components as in inflammatory bowel disease. Conventional therapy for AD consists of elimination of exacerbating factors, moisturizers to maintain skin hydration, antihistamines to alleviate pruritus, topically applied corticosteroids, or topical calcineurin inhibitors to control inflammation. Severe forms of atopic dermatitis may need systemic corticosteroids, oral cyclosporine, and/or phototherapy.

Probiotics have been suggested as a novel treatment approach for atopic dermatitis. Specific probiotics have been shown to normalize intestinal permeability, to counteract intestinal immune dysfunction and to normalize gut dysbiosis. Hence, their clinical benefit may reside in the control of gut inflammation induced by various intraluminal antigens and enhancement of adaptive and especially innate immune responses.

Indeed, above and beyond balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms. However, there are conflicting evidence on the utility of selected probiotic strains for atopic dermatitis, and major problems are due to dose and viability of strain used, duration of treatment, study population.

The aim of this randomized, double-blind, placebo-controlled study is to evaluate the efficacy of the most studied probiotic in the pediatric allergy field - Lactobacillus rhamnosus GG (LGG) - in children affected by atopic dermatitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-36 months
  • diagnosis of Atopic Dermatitis according to SCORAD index

排除标准

  • Age < 6 months
  • age > 36 months,
  • skin infections,
  • ichthyosis,
  • food allergies,
  • other allergic diseases,
  • 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 and/or respiratory tract,
  • administration of prebiotics/ probiotics/symbiotic/systemic immunomodulators during the 4 weeks before enrolment,
  • treatments with topical immunomodulators (Tacrolimus or Pimecrolimus) over the three months prior to enrolment;
  • use of corticosteroids or calcineurin antagonists or phototherapy in the previous 4 weeks,
  • use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
  • investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
  • participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
  • hypersensitivity to components contained in study product.

研究组 & 干预措施

Lactobacillus rhamnosus GG

Experimental

Lactobacillus rhamnosus GG (10 billion Colony Forming Units/CAPSULE)

干预措施: Lactobacillus rhamnosus GG (Dietary Supplement)

placebo

Placebo Comparator

maltodextrin

干预措施: placebo (Other)

结局指标

主要结局

Reduction of SCORing Atopic Dermatitis (SCORAD)

时间窗: after 12-week treatment

The efficacy of LGG supplementation on clinical course of children in terms of reduction of SCORAD index (score minimum 0 - maximum 60)

次要结局

  • Composition of gut microbiota metabolomic feature(after 12-week treatment)
  • Composition of gut microbiota(after 12-week treatment)
  • evaluation acquired immunity(after 12-week treatment)
  • evaluation of quality of life(after 12-week treatment)

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

Associate Professor

Federico II University

研究点 (2)

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