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NCT Number: NCT07417085

MICRO-BRAIN 2024: Study on Pediatric Brain Tumors

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.

Recruiting

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meyer Children's Hospital IRCCS

Florence, Firenze, 50139, Italy

Location status: Recruiting

Location contact

Iacopo Sardi

CONTACT

[email protected]

0555662631

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Registry information

Official study title

Implications and Applications of Microbiota in Pediatric Brain Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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