NCT00944736已完成3 期
Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission
Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Intestinal Permeability - measured by Sugar Absorption Test
研究概览
简要总结
The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.
详细描述
Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and endoscopic criteria.
- •Males or females ages 11-17 years.
- •Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) < 10
- •Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for at least 2 months.
- •Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.
排除标准
- •Patients with documented intestinal stricture.
- •Patients with signs of symptoms of systemic or intestinal infection.
- •Antibiotic use the previous 1 month.
- •Probiotic use in the previous 2 months (excluding yogurt).
- •Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus and Infliximab.
- •Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease.
- •Patients with indwelling catheters.
- •Patients with short bowel syndrome
- •Positive urine pregnancy test for female subjects
结局指标
主要结局
Intestinal Permeability - measured by Sugar Absorption Test
时间窗: 3 months
次要结局
未报告次要终点
研究者
Julia Bracken
Assistant Professor of Medicine
Children's Mercy Hospital Kansas City
研究点 (2)
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