Actively Recruiting

Phase Not Applicable
Age: 3Years - 18Years
All Genders
Healthy Volunteers
NCT07417085

MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

Led by Meyer Children's Hospital IRCCS · Updated on 2026-02-18

100

Participants Needed

1

Research Sites

138 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

Who Can Participate

Age: 3Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Meyer Children's Hospital IRCCS

Florence, Firenze, Italy, 50139

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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