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临床试验/NCT03042624
NCT03042624Unknown不适用

Efficacy of Fermented Rice Flour for the Treatment of Atopic Dermatitis: Randomized, Double-blind Controlled Trial

University of Milan2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年1月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
SCORAD change

研究概览

简要总结

This trial aims at evaluating the efficacy of a fermented rice flour for the treatment of atopic dermatitis (AD).

The fermented rice flour, obtained from Lactobacillus paracasei CBA L74 (Heinz Italia SpA, Latina, Italy), does not contain live bacteria. Lactobacillus paracasei CBA L74 belongs to the list of microorganisms with qualified presumption of safety compiled by the European Food Safety Authority (EFSA), is tested for the absence of antibiotic resistance genes in accordance with EFSA, and is genetically characterized by repetitive extragenic palindromic polymerase chain reaction.

Using a repeated-measure cohort design, the investigators have recently shown that the administration of a fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was associated with a decrease of the score for atopic dermatitis (SCORAD) in children with AD.

The present randomized, double-blind, controlled trial is aimed at testing whether the fermented rice flour obtained from Lactobacillus paracasei CBA L74 is effective in reducing SCORAD in children with moderate to severe AD using placebo as comparator.

详细描述

Atopic dermatitis (AD), an itchy eczema with a chronic relapsing course, is the most common clinical manifestation of atopy in the first years of life.

On the basis of the available knowledge, AD is produced by an alteration of the skin barrier which triggers an inflammatory reaction. Such reaction is characterized by an early phase with abundance of Th2 cytokines (IL-4, IL-5) and eosinophils and by a later phase with predominance of Th1 cytokines (IL-2, IL-12 and IFN-gamma).

Emollients, possibly supplemented with ceramides, represent the first step of the treatment of AD. Corticosteroids are the most effective topical drugs. The use of topical immune-modulators (tacrolimus and pimecrolimus) offers an alternative to steroid therapy for long-term treatments. Severe cases require systemic therapy with steroids and cyclosporine and phototherapy with narrowband ultraviolet (UVB) and psoralen-ultraviolet A (PUVA) phototherapy.

The use of probiotics for the treatment of AD has attracted much interest in recent years but the available data are not conclusive. Probiotic-like effects can be obtained from inactivated bacteria or isolated bacterial components so that an extensive definition of probiotics has been proposed as bacterial cells or bacterial components that have a beneficial impact on the health and well-being of guests.

Using a repeated-measure cohort design, the investigators have recently shown that the administration of the fermented-rice flour obtained from Lactobacillus paracasei CBA L74 was associated with a decrease of SCORAD (score for atopic dermatitis) in children with AD.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Each treatment is numbered consecutively without any reference to the underlying randomization scheme, which is known only to the statistician who generated the list and to the technician who prepared the packages. The packages and their contents are indistinguishable.

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

  • diagnosis of moderate or sever atopic dermatitis using SCORAD

排除标准

  • acute rhino-conjunctivitis
  • acute asthma
  • autoimmune disease
  • chronic obstructive pulmonary disease
  • heart disease
  • renal disease
  • treatment with prebiotics 1 month before the enrolment
  • treatment with probiotics 1 month before the enrolment
  • treatment with antibiotics (undergoing)
  • treatment with systemic immune-modulators 1 month before the enrolment
  • treatment with local immune-modulators 1 month before the enrolment
  • acute or chronic infectious disease
  • known hypersensitivity to components of fermented rice flour

结局指标

主要结局

SCORAD change

时间窗: 12 weeks

The treatment will be stopped at 12 weeks

次要结局

  • SCORAD change(16 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gian Vincenzo Zuccotti

Professor of Pediatrics

University of Milan

研究点 (2)

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