Clinical trial Recruiting at 1 site Interventional Ages 3 to 18

Gut microbiota in children with suspected brain tumors

Official title: Implications and Applications of Microbiota in Pediatric Brain Tumors

Run by Meyer Children's Hospital IRCCS · NCT07417085 · Data updated 2026-11-12

This will test whether stool samples can reveal gut microbiota differences in children aged 3–18 who are suspected of having a central nervous system (CNS) tumor.

Quick facts

Study typeInterventional
Ages3 Years to 18 Years
SexAll
Enrollment100 (estimated)
SponsorMeyer Children's Hospital IRCCS
Academic / other
Locations1 site (Florence, Firenze)
StatusRecruiting
StartedFebruary 6, 2025
Main results expectedApril 2027
Study endsOctober 2027
Registry record updatedFebruary 18, 2026
Trial IDNCT07417085 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 3–18 with a suspected intracranial or spinal CNS tumor who are scheduled for neurosurgery, have not had prolonged antibiotics or probiotics in the past three months, and whose parent/guardian provides consent.

Probably not a fit

Children with chronic inflammatory or congenital gastrointestinal diseases, prior cancer treatments, recent prolonged antibiotic/probiotic use, or whose tumor diagnosis cannot be confirmed by histology are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect fecal samples from children aged 3–18 who are undergoing neurosurgery for a suspected central nervous system tumor and who have not received prolonged antibiotics or probiotics in the prior three months. The samples will be analyzed to characterize microbial diversity and composition and to look for patterns linked to tumor presence or biology. Children with chronic gastrointestinal diseases, prior cancer treatments, or whose tumor diagnosis cannot be confirmed by histology are excluded. The project aims to generate the first pediatric dataset linking gut microbiota profiles to CNS tumors and to inform future diagnostic or therapeutic research.

Why it matters

Potential benefit: If successful, the study could identify gut microbiota patterns that help guide future diagnosis, risk stratification, or microbiome-targeted therapies for children with brain tumors.

How similar studies have gone: Adult and some cancer-specific studies have shown altered microbiota in cancer patients, but stool-based microbiota analysis specifically in pediatric CNS tumors appears novel with no reported prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Meyer Children's Hospital IRCCS
    Florence, Firenze, Italy
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.