Butyrate Therapy in Hispanic Children With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- remission of clinical disease
研究概览
简要总结
Butyrate is an important metabolite produced by the gut microbiome and has been shown as a helpful therapy in ulcerative colitis. This is a feasibility study to determine the efficacy of butryate enemas in pediatric ulcerative colitis.
详细描述
butyrate enemas will be administered for 12 weeks to children ages 7 to 21 with mild to moderate ulcerative colitis to determine if butyrate therapy can help improve the clinical disease in those children. standard management of the disease will be performed during these 12 weeks including routine laboratory studies and endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7-21 years, mild to moderate ulcerative colitis
排除标准
- •UC therapy within 4 weeks of study medication initiation
- •infectious colitis, -pregnancy
研究组 & 干预措施
open label intervention arm
Butyrate enemas will be administered once daily for twelve weeks.
干预措施: Butyrate (Drug)
结局指标
主要结局
remission of clinical disease
时间窗: 12 weeks
pediatric ulcerative colitis activity index, remission is \<10, mild disease 10-34, moderate 35-64, severe 65 or greater
次要结局
- improvement of inflammatory markers including ESR, CRP, Calprotectin(12 weeks)
研究者
Sonia Michail, MD
Principal Investigator
Children's Hospital Los Angeles