Clinical trial · Observational
The Oronasal Microbiota in Pediatric Oncology Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The human microbiome is composed of unique groups of microorganisms occupying distinct habitats distributed throughout the human body. The Human Microbiome Project recently evaluated the bacterial composition of the microbiome in 18 (for women) and 15 (for men) body sites. Much initial attention in the field of microbiome research has focused on the bacterial contribution to a "healthy" microbiome. However, it is clear that other microorganisms, including fungi and viruses, are also distributed throughout the human body and serve as functional components of the microbiome. The populations of microorganisms residing within the oral and nasal cavities make important contributions to human health and disease. These contributions may be especially important in immunosuppressed patients, including those patients receiving myelosuppressive chemotherapy or undergoing hematopoietic stem cell transplantation. In these patients, organisms typically considered as commensals can become pathogenic, either locally or systemically. This observational study is primarily undertaken to evaluate the oral and nasal microbiota and to define the population of fungal organisms residing within the oral and nasal cavities in pediatric oncology patients before and after receiving protocol-directed chemotherapy and associated supportive care.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Bone Marrow Transplantation | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Diversity index of oronasal fungal microbiome (mycobiome)
- timeFrame
- Start of therapy through completion of therapy (up to 2 years)
- description
- Diversity index is a measure of the richness of microbial species present in the sample. It is a single summary continuous numerical quantity for each sample.
- measure
- Relative abundance of the oronasal fungal microbiome
- timeFrame
- Start of therapy through completion of therapy (up to 2 years)
- description
- Relative abundance is percentage of each taxa of fungal, describing which fungal species are detected in a sample.
Secondary outcomes (4)
- measure
- Diversity index of oronasal bacterial microbiome
- timeFrame
- Start of therapy through completion of therapy (up to 2 years)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 4 to 21 years. * Group 1: Patients with newly confirmed diagnosis of acute myeloid leukemia (AML). * Group 2: Patients scheduled to receive conditioning for allogeneic HSCT within 7 days. Exclusion Criteria: * Patients in group 1 who have received chemotherapy for more than 72 hours prior to enrollment (group 1) or started preparative regimen for allogenic stem cell transplant (group 2). * Patients who are unable to perform the oral rinse or nasal swab collection procedure. * Patients who have any condition that would place them at unnecessary risk secondary to providing oral and nasal samples. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent for study participation.
References
Publications (0)
Data not yet available