Multicentre Observational Cohort Study in Newly Diagnosed Crohn's Disease Patients Aimed at Identifying Intestinal Microbial Profiles Correlated With Low and High Risk of Severe Disease Course
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy)
研究概览
简要总结
Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.
The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children/young people aged between 6 and 18 years with newly diagnosed CM according to recognised diagnostic criteria
- •Obtaining informed consent
排除标准
- •Refusal to participate in the study.
研究组 & 干预措施
patient with Chron's Disease
Only patient with Crohn's Disease
干预措施: Collection biological sample and analysis (Other)
结局指标
主要结局
Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy)
时间窗: 3 years after beginning of the study
Detection of differences in alpha and beta diversity in stool microbiome in various phases of disease course, at diagnosis, remission and after one year of mantainance therapy
次要结局
- Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk(3 years after beginning of the study)
- Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification(3 years after beginning of the study)
研究者
Paolo Lionetti
Principal Investigator
Meyer Children's Hospital IRCCS