NCT06755307招募中不适用
PROBIOTICS FOR TREATING DIAPER DERMATITIS IN CHILDREN - A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL
University Maribor2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年8月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Duration of diaper dermatis
研究概览
简要总结
The goal of this randomized controlled clinical trial is to determine the effect of the probiotic OMNiBiOTiC® Panda in treating diaper dermatitis in children under the age of two years. The main question it aims to answer is:
Is the probiotic OMNiBiOTiC® Panda effective in reducing the duration of diaper dermatitis in children under the age of two years?
Researchers will compare the probiotic and placebo group to see if the duration of diaper dermatitis is significant among the two groups.
Participants will:
- receive 6 droplets daily of probiotic or placebo for 3 weeks and
- observe and record improvement of diaper rash symptoms each day using a diary.
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 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of diaper dermatitis
- •age less than two years
排除标准
- •previous use of probiotics
- •age more than two years
- •an acute bacterial infection
- •chronic disease
- •local use of antibiotics in the anogenital region
结局指标
主要结局
Duration of diaper dermatis
时间窗: 3 weeks supplementation
Comparison of the duration of diaper dermatitis in children younger than two years in both arms via daily the use of the diary.
次要结局
未报告次要终点
研究者
Sabina Fijan
Assoc. Prof. Dr.
University Maribor
研究点 (2)
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