Probiotics and Allergic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The Effects of probiotics in improving life quality and symptomatic severity
研究概览
简要总结
Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant treatment of atopic dermatitis and asthma.
详细描述
The main purpose: To investigate if Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090(LF), Lactobacillus paracasei GMNL-133 (LP) with Lactobacillus fermentum GM-090 (LF) combination products could be used for the adjuvant treatment of atopic dermatitis and asthma.
The Secondary Objective: To investigate whether probiotics consumption improve the quality of life and allergic symptoms to different people with Lactobacillus paracasei GMNL-133 (LP), Lactobacillus fermentum GM-090 (LF) and Lactobacillus paracasei GMNL-133(LP) and Lactobacillus fermentum GM-090 (LF) combination products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 1 year old and 18 years old,
- •AD cases fulfill the diagnostic criteria by Hannifin and Rajka.
- •Atopy as shown by at least one positive skin test (weal size ≧ 3mm) or one positive MAST (RAST) (IgE ≧ 0.7 kU/L) test to any common food or environmental allergens.
排除标准
- •Systematic corticosteroid, immunosuppressive therapy, or antimycotics treatment during the 4 weeks, antihistamines, and singulair during the 7 days before enrollment
- •Probiotic preparations used within 2 weeks before entering the study
- •Use of antibiotics now or other oral medications that will interfere the results
- •If they had immune deficiency disease or other major medical problems
- •If they had participated in another clinical study during the past month.
- •Subjects are undergoing desensitization therapy within 3 months prior to the screening period.
- •Subjects have participated investigational drug trial within 4 weeks before entering this study.
- •Subjects are pregnant, lactating or planning to become pregnant.
- •Subjects with any other serious diseases considered by the investigator that could interfere with the performance of SCORAD score result.
- •Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
研究组 & 干预措施
LP GMNL-133+LF GM-090 group
One capsule with 2x10^9 (cfu) LP GMNL-133+ 2x10^9 (cfu)LF GM-090, once daily, PO
干预措施: LP GMNL-133 +LF GM-090 capsule (Biological)
Placebo
干预措施: Placebo (Biological)
LP GMNL-133 group
Arm: LP GMNL-133 group One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
干预措施: LP GMNL-133 capsule (Biological)
LF GM-090 group
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
干预措施: LF GM-090 capsule (Biological)
结局指标
主要结局
The Effects of probiotics in improving life quality and symptomatic severity
时间窗: 2 years
1. Atopic dermatitis Primary Endpoints: SCORAD score, Children's Dermatology Life Quality Index (CDLQI), and Dermatitis Family Impact Questionnaire 2. Asthma Primary Endpoints: GINA guideline asthma severity ( step up or step down) ACT, PAQLQ, PACQLQ, PASS Questionnaire 3. Allergic Rhinitis Primary Endpoints: ARIA allergic rhinitis severity PRQLQ, NTSS Questionnaire
次要结局
- The Effects of probiotics on biomakers and other symptom relief(2 years)