Gut microbiota in children with suspected brain tumors
Implications and Applications of Microbiota in Pediatric Brain Tumors
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Meyer Children's Hospital IRCCS Academic / other |
| Locations | 1 site (Florence, Firenze) |
| Trial ID | NCT07417085 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Florence, Firenze
- Meyer Children's Hospital IRCCS — Florence, Firenze, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.