MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

NCT07417085 | Recruiting

• 1 other identifier: MICRO-BRAIN 2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Tumor; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients

OTHER

Pediatric patients with brain tumors

Diagnostic Test: Biological samples

Controls

OTHER

Pediatric subjects not affected by brain tumor

Diagnostic Test: Fecal samples

Interventions

Biological samples DIAGNOSTIC_TEST

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

Patients

Fecal samples DIAGNOSTIC_TEST

Analysis of fungal and bacterial genomic DNA from fecal samples

Controls

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (1)

Meyer Children's Hospital IRCCS

Florence, Firenze, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 18, 2026
• Study Start: February 6, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)