Skip to content

MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

Implications and Applications of Microbiota in Pediatric Brain Tumors

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07417085
Enrollment
100
Registered
2026-02-18
Start date
2025-02-06
Completion date
2027-10-01
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Microbiota

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.

Interventions

DIAGNOSTIC_TESTBiological samples

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

DIAGNOSTIC_TESTFecal samples

Analysis of fungal and bacterial genomic DNA from fecal samples

Sponsors

Meyer Children's Hospital IRCCS
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Change in the composition of the microbiotaAt enrollment; 6 months post-enrollment; on the date of the first documented progression assessed up to 36 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026