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Recruiting Not applicable

MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

NCT07417085 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-02-06
Last updated
2026-02-18

Condition(s) studied

Brain TumorMicrobiota

Investigational drug(s) / intervention(s)

Biological samplesFecal samples

Biological samples: Analysis of fungal and bacterial genomic DNA from fecal samples, rectal swabs, and tumor biopsy

Fecal samples: Analysis of fungal and bacterial genomic DNA from fecal samples

Study summary

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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
18 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Change in the composition of the microbiota — At enrollment; 6 months post-enrollment; on the date of the first documented progression assessed up to 36 months

Trial sites (1)

FacilityCityRegionStatus
Meyer Children's Hospital IRCCS Florence Firenze Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07417085 on ClinicalTrials.gov ↗ ← All trials in Italy