NCT07417085 MICRO-BRAIN 2024: Study on Pediatric Brain Tumors
| NCT ID | NCT07417085 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Meyer Children's Hospital IRCCS |
| Condition | Brain Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-02-06 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Frequently Asked Questions
Who can join the NCT07417085 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Brain Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07417085 currently recruiting?
Yes, NCT07417085 is actively recruiting participants. Visit ClinicalTrials.gov or contact Meyer Children's Hospital IRCCS to inquire about joining.
Where is the NCT07417085 trial being conducted?
This trial is being conducted at Florence, Italy.
Who is sponsoring the NCT07417085 clinical trial?
NCT07417085 is sponsored by Meyer Children's Hospital IRCCS. The trial plans to enroll 100 participants.