EFFECT OF PROBIOTICS IN THE TREATMENT OF ATOPIC DERMATITIS IN CHILDREN - A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Decrease in SCORAD Index - scoring criteria for a topic dermatitis
研究概览
简要总结
The purpose of this trial is to study the effect of Probiotics in the treatment of a topic dermatitis in children. The primary objective is to assess decrease in SCORAD Index which denotes the clinical severity of the disease. This trial also studies the changes in skin and gut microflora, absolute eosinophil counts, IgE antibody titres and trans epidermal water loss. All children from 6 months to 18 years attending JIPMER Pediatrics and Dermatology OPD who are meeting the inclusion criteria will be alloted to two groups A and B. Group A will receive Probiotics - lactobacillus rhamnosus GG 10 billion CFU per packet/sachet daily for a period of 3 months and group B will receive the placebo for 3 months along with the standard treatment. Skin and blood samples will be collected before and after Probiotics supplementation. Stool samples to demonstrate the gut microflora will be collected from one fourth of study population at the end of 3 months. Transepidermal water loss will be measured using a non invasive probe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •All children from 6 months till 18 years attending JIPMER Pediatrics and Dermatology OPD.
排除标准
- •Children with acute gastrointestinal infections.
- •Children with chronic underlying disease on immunosuppressive therapy.
- •Children with known or suspected immunodeficiency.
- •Children on prolonged antibiotic therapy and antituberculuos therapy.
- •Children who are a part of other studies.
结局指标
主要结局
Decrease in SCORAD Index - scoring criteria for a topic dermatitis
时间窗: Decrease in SCORAD index to be assessed every week following Probiotics supplementation
次要结局
- 1) Change in skin microflora assessed by skin cultures(2) Change in IgE antibody titres measured by IgE ELISA kits)