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MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

RecruitingNAAges 3 Years - 18 YearsAllMeyer Children's Hospital IRCCS
NCT07417085 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
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What it tests

  • Biological samples
  • Fecal samples
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Where

1 site
Meyer Children's Hospital IRCCS
Florence, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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