Safety and Feasibility of Oligofructose-Enriched Inulin in Pediatric Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Alteration of gut microbiota and metabolome
研究概览
简要总结
The purpose of this study is to see how the prebiotic inulin changes the gut bacteria (microbiome) of children and young adults with IBD and determine if this dietary intervention can help reduce disease activity.
详细描述
The pathogenesis of inflammatory bowel disease (IBD) is thought to be due to a combination of genetic, environmental and immunological factors. From a clinical stand point, there is great interest in determining if manipulation of the gut microbiota may be a viable therapeutic strategy in IBD patients. One such strategy involves the use of prebiotic. Prebiotics are oligosaccharides that cannot be enzymatically hydrolyzed in the small intestine, however serve as substrates for fermentation by commensal bacteria in the colon.
Investigators propose to evaluate the modulatory effects of the prebiotic inulin on the composition and function of the microbiota of children with IBD and determine the efficacy of this dietary intervention in reducing disease activity.
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
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Alteration of gut microbiota and metabolome
时间窗: 8 weeks
The primary outcome will be assessed based on specific inulin-induced changes in microbiome composition and metabolome with a focus on short-chain fatty acid (SCFA) producers and their metabolites at week 8.
次要结局
- Change in fecal calprotectin level(8 weeks)