Lactobacillus Paracasei LPB27 On Early Childhood Eczema
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Proportion of patients achieving treatment success
研究概览
简要总结
The LaCE study is a double-blind, randomised, placebo-controlled trial examining the effectiveness of the probiotic Lactobacillus paracasei LPB27 in treating eczema in young children.
详细描述
Childhood eczema is a common and chronic, relapsing disease of the skin which affects up to 20% of the paediatric population. Eczema has significant impact on the quality of life of those affected. Its main symptoms are dry skin and intense itching.
There is currently no cure for eczema but there are treatments that try to relieve symptoms. These commonly include topical moisturisers and topical corticosteroids.
Although topical corticosteroids are effective in minimising symptoms, there is a prevailing and universal fear of using topical corticosteroids which is one of the main reasons for poor treatment compliance.
There have been emerging interests in prevention and treatment of eczema through modulation of the gut microbiome. The gut microbiome is a key regulator for the immune system and there is evidence that the composition of gut microbiome may reduce allergies by driving maturation of the immune system. It was shown that people with eczema have different bacteria in their gut compared to people without eczema. Therefore, this study's hypothesis is that administration of oral probiotics will benefit young children with eczema by improving their gut microbiome and quality of life.
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, Investigator)
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 3 months to 3 years old
- •Diagnosis: Eczema (atopic dermatitis) diagnosed clinically by a paediatric dermatologist or immunologist.
- •Severity: Investigator Global Assessment for Atopic Dermatitis (IGA) severity of 1-3 (almost clear, mild, moderate) and a SCORAD score greater than 8.
- •Willingness and ability of the subject to comply with the protocol requirements.
排除标准
- •Patients on systemic immunosuppression and/or biologic agents (participants who start systemic immunosuppression and/or biologic agents mid-way through the study will be considered to have not achieved treatment success and will be withdrawn, regardless of their SCORAD index scores).
- •Mothers who are breastfeeding and on probiotics but not willing to stop probiotics.
- •Child already on probiotics and parents not willing to stop during the entire study period (washout period of 4 weeks; including formulas that contains probiotics).
- •Eczema complicated by active skin infection e.g. impetigo/cellulitis/ eczema herpeticum (can be considered once active infection resolved).
- •Child currently on oral or IV antibiotics (washout period of 4 weeks allowable once antibiotics completed). Participants who require antibiotics after being enrolled in the study may continue on the study as usual.
- •Immunodeficient disorders.
- •Chronic disorder involving the gastrointestinal tract (e.g., inflammatory bowel disease, short gut syndrome, cystic fibrosis).
- •Known hypersensitivity to components contained in study product.
结局指标
主要结局
Proportion of patients achieving treatment success
时间窗: Between baseline and 12 weeks
Clinically meaningful reduction (\>= 8.7 points) in SCORAD index between baseline and 12 weeks without the use of rescue medication (systemic immunosuppression and/or biologic agents)
次要结局
- Mean change in SCORAD index(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- First use of rescue medication(From baseline to time of starting rescue medication (up to 12 weeks))
- Mean change in RECAP(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Mean change in IDQOL(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Mean change in EASI(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Mean change in IGA(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Mean change in POEM(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Use of topical corticosteroids(From baseline to 12 weeks)
- Mean change in TOPICOP score(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Mean change in gut microbiota(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
- Mean change in skin microbiota(From baseline to 12 weeks or time of starting rescue medication (whichever occurs earlier))
研究者
Keith Chee Y. Ooi
Professor
The University of New South Wales