Reduction in Frequency of Infliximab Administration From q 8 Weeks to q 12 Weeks in Children With Crohn's Disease Receiving Probiotic VSL#3 Supplementation: A Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Reduction in Frequency of Infliximab Administration from q 8 Weeks to q 12 Weeks in Children with Crohn's Disease Receiving Probiotic VSL#3 Supplementation
研究概览
简要总结
The purpose was to evaluate as to whether administration of infliximab of 12 week interval with supplementary VSL#3 is more effective or at least of similar efficacy when compared to conventional administration of infliximab only of 8 week interval.
详细描述
The purpose of our study was to evaluate if supplementation of VSL#3 can improve treatment outcome for those pediatric Crohn's patients treated with infliximab every 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment
- •confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings
排除标准
- •patients who has proven to have infliximab antibody
结局指标
主要结局
Reduction in Frequency of Infliximab Administration from q 8 Weeks to q 12 Weeks in Children with Crohn's Disease Receiving Probiotic VSL#3 Supplementation
时间窗: 1-year treatment period
Disease Activity Index (PCDAI) scores, hematocrit, albumin, ESR, CRP, TNF-α, IL-8, INF-γ, and endoscopic findings (Simple Endoscopic Score for Crohn's Disease was used) were assessed
次要结局
未报告次要终点
研究者
YonHo Choe
Pediatrics
Samsung Medical Center