Implications and Applications of Microbiota in Pediatric Brain Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the composition of the microbiota
研究概览
简要总结
In recent years, there has been growing interest in the human gut microbiota, whose health is characterised by high microbial diversity. Through the gut-brain axis, the microbiota influences the homeostasis of the central nervous system by regulating neurological, immune and epigenetic functions. Intestinal dysbiosis is associated with various neurological and oncological diseases, including paediatric diseases and colorectal cancer. Recent studies highlight a significant link between microbiota and brain tumours: cancer patients show reduced microbial richness and altered bacterial composition. In addition, an intratumoural microbial population has been identified that can influence tumour initiation, progression and response to therapies by modulating tumour cells and the immune system. The aim of this study is to analyse stool samples to study the microbiota in children suspected CNS brain tumor as there are currently no studies of this kind reported in the literature to assess whether microbial changes can be detected at diagnosis, can be found during the course of the disease or are associated with tumour progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 3 and 18 years with suspected CNS tumour undergoing neurosurgery (intracranial and spinal localisation)
- •Patients who have not undergone prolonged antibiotic or probiotic therapy in the three months prior to sample collection.
- •Signature of informed consent form.
排除标准
- •personal history of chronic inflammatory bowel disease (colitis, Crohn's disease, ulcerative colitis) and congenital or acquired gastrointestinal diseases (coeliac disease, diverticulitis and diverticulosis, peritonitis, Hirschsprung's disease, short bowel syndrome, intestinal malrotation or duplication, intestinal atresia, omphalocele, presence of stomas, acute gastroenteritis)
- •history of previous cancer-related treatments
- •diagnosis of brain tumour not confirmed by histology (data obtainable post-surgery)
研究组 & 干预措施
Patients
Pediatric patients with brain tumors
干预措施: Biological samples (Diagnostic Test)
Controls
Pediatric subjects not affected by brain tumor
干预措施: Fecal samples (Diagnostic Test)
结局指标
主要结局
Change in the composition of the microbiota
时间窗: At enrollment; 6 months post-enrollment; on the date of the first documented progression assessed up to 36 months
次要结局
未报告次要终点
研究者
Iacopo Sardi
Principal Investigator
Meyer Children's Hospital IRCCS
