Beyond Conventional Treatment of Atopic Eczema in Infants: Management By Specific prObiOtic Strains
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- decrease in severity of atopic dermatitis
研究概览
简要总结
To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in laboratory setting and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD severity in young children (beyond the conventional treatment).
详细描述
Atopic dermatitis (AD) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. The disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. Approximately 40% of the children with AD will develop asthma later in childhood.
Currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. There is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. Modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease.
Clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. Systematic (Cochrane) reviews of all clinical trials (about treatment of AD by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for AD; however, there is great heterogeneity between studies since many different probiotic strains are used. Because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others.
Better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.
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
- 1 Day 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children 0-15 months with mild to moderate eczema (SCORAD score 15-50 or equally EASI score) for at least two weeks
排除标准
- •use of topical steroids class II or higher (which means treatment for severe eczema),
- •use of oral steroids or treatment with antibiotics prior to inclusion.
- •severe comorbidity
- •lack of knowledge of the Dutch language
结局指标
主要结局
decrease in severity of atopic dermatitis
时间窗: 6 months
The primary outcome will be measured by change in the severity of AD by using the SCORAD score. Other outcomes: subjective (parental) change in eczema severity, change in amount of and type of topical steroid use, quality of life during and after intervention (measured by ITQOL questionnaire), amount of respiratory tract infections, use of antibiotics, use of primary care medicine (general practitioner). All used probiotic strains contain the QPS status. (serious) adverse events will be recorded systematically.
次要结局
- Effects on the immature immune system(6 months)
- Effects on infant gut microbiota(6 months)