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.
Participants will be recruited from the patient population at the St. Jude Children's Research Hospital (SJCRH). Participants will be enrolled in the study according to their underlying primary diagnosis: acute myeloid leukemia (AML) and in patients undergoing hematopoietic stem cell transplantation (HSCT). Patients will be asked to provide an oral wash and nasal swab sample at three time points during the course of their treatment at SJCRH. These samples will be used to characterize comprehensively the oronasal microbiota. * Group 1 will include 30 patients with newly diagnosed AML. Within 72 hours of the start of chemotherapy, patients will provide an oral rinse and nasal swab sample. Participants will provide two subsequent oral rinse and nasal swab samples. The first (second total oral rinse and nasal swab sample) will be provided within 7 days of completion of "induction II" of therapy. The second (third total oral rinse and nasal swab sample) will be collected within 7 days of completion of therapy. * Group 2 will include 30 allogeneic HSCT recipients. Prior to beginning their conditioning regimen, patients will provide an oral rinse and nasal swab sample. Participants will provide two subsequent oral rinse and nasal swab samples. The first (second total oral rinse and nasal swab sample) will be collected after completing their conditioning regimen on day +10 (plus or minus 7 days). The second (third total oral rinse and nasal swab sample) will be collected on day +30 (plus or minus 7 days).
Study Type
OBSERVATIONAL
Enrollment
62
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Diversity index of oronasal fungal microbiome (mycobiome)
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.
Time frame: Start of therapy through completion of therapy (up to 2 years)
Relative abundance of the oronasal fungal microbiome
Relative abundance is percentage of each taxa of fungal, describing which fungal species are detected in a sample.
Time frame: Start of therapy through completion of therapy (up to 2 years)
Diversity index of oronasal bacterial microbiome
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.
Time frame: Start of therapy through completion of therapy (up to 2 years)
Relative abundance of the oronasal bacterial microbiome
Relative abundance is percentage of each taxa of bacteria, describing which bacterial species are detected in a sample.
Time frame: Start of therapy through completion of therapy (up to 2 years)
Diversity index of the oronasal viral microbiome
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.
Time frame: Start of therapy through completion of therapy (up to 2 years)
Relative abundance of the oronasal viral microbiome
Relative abundance is percentage of each taxa of viruses, describing which viral species are detected in a sample.
Time frame: Start of therapy through completion of therapy (up to 2 years)
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