An Innovative Probiotic Product With Antiallergic Properties. The Effectiveness of a Mixture of Lactobacillus ŁOCK Strains in Children With Atopic Dermatitis - Multicentre, Randomized, Double-blind Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms
研究概览
简要总结
Allergic diseases are currently one of the most important problem in medicine. Research confirms that probiotics administered during the formation of the intestinal ecosystem and the maturation of the immune system can positively influence the development of antiallergic mechanisms. The aim of the present randomized, double-blind, placebo controlled study was to evaluate the efficacy of the mixture of probiotic Lactobacillus rhamnosus ŁOCK 0900, Lactobacillus rhamnosus ŁOCK 0908, and Lactobacillus casei ŁOCK 0919 in children up to the age 2 with atopic dermatitis and food allergy to cow's milk proteins. Children received the mixture of Lactobacillus strains for 3 months every day in the daily dose of a billion bacteria or a placebo (maltodextrin). Primary outcomes included the effects of probiotic treatment on the severity of symptoms assessed with SCORing atopic dermatitis (SCORAD) index. Secondary endpoints included assessment of total IgE and selected cytokine levels. Cytokines were evaluated in supernatants obtained from peripheral blood cultures of randomly selected 20 patients from each group. The primary and secondary outcomes were assessed at 3 time points: at baseline, after the finishing the administration of probiotic/placebo, and after 9 months of follow up.
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 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of atopic dermatitis according to Hanifin and Rajka criteria,
- •age under 2 years (24 months)
- •the SCORAD index >10
- •suspected allergy to cow's milk protein
排除标准
- •acute infections of skin,
- •presence of other severe diseases
- •treatment with systemic corticosteroids
- •treatment with antibiotics for at least 6 weeks prior to study enrollment
- •use of probiotics for the last 6 weeks prior to study enrollment
结局指标
主要结局
Changes in proportion of children with improvement or worsening of atopic dermatitis symptoms
时间窗: From baseline at 3 months of intervention and 9 months of follow up
Atopic dermatitis symptoms were assessed with the use of the SCORAD index. It was assumed that a drop \>30% in the SCORAD index compared with baseline was associated with a clinically meaningful improvement. A drop\<30% was associated with worsening.
Changes in severity of atopic dermatitis symptoms assessed with the use the SCORAD index
时间窗: From baseline at 3 months of intervention and 9 months of follow up
The SCORAD index consists of the interpretation of the extent of the disorder (A: according to the rule of nines; 20% of the score), the intensity composed of six items (B: erythema, oedema ⁄papules, effect of scratching, oozing ⁄crust formation, lichenification and dryness; 60% of the score; each item has four grades: 0,1, 2, 3) and subjective symptoms (C: itch, sleeplessness; 20% of the score). Both subjective items are graded on a 10-cm visual analogue scale. The SCORAD index formula is: A ⁄5 + 7B⁄2 + C. In this formula A is defined as the extent (0-100), B is defined as the intensity (0-18) and C is defined as the subjective symptoms (0-20). The maximum SCORAD score is 103.
次要结局
- Changes in the level of selected cytokines(From baseline at 3 months of intervention and 9 months of follow up)
- Changes in the level of total IgE(From baseline at 3 months of intervention and 9 months of follow up)
研究者
Bożena Cukrowska
professor of medicine, MD, PhD
Children's Memorial Health Institute, Poland