MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

Conditions

• Brain Tumor
• Microbiota

Eligibility Criteria

Sex

ALL

Age

3 Years - 18 Years

Healthy Volunteers

Accepted

Interventions

• Biological samples — DIAGNOSTIC_TEST
  Analysis of fungal and bacterial genomic DNA from fecal samples, rectal swabs, and tumor biopsy
• Fecal samples — DIAGNOSTIC_TEST
  Analysis of fungal and bacterial genomic DNA from fecal samples

Study Details

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.

Key Dates

First listed

Feb 18, 2026

Start date

Feb 6, 2025

Status verified

Feb 2026

Primary completion

Apr 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Other: Patients
  Pediatric patients with brain tumors
• Other: Controls
  Pediatric subjects not affected by brain tumor

Primary Outcome Measure

Change in the composition of the microbiota [ Time Frame: At enrollment; 6 months post-enrollment; on the date of the first documented progression assessed up to 36 months ]

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