Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Orthopedic, Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | May 2015 |
| End Date: | April 2016 |
Comparison of the Fecal Microbiome, Peripheral Inflammatory Markers, and Symptoms in Individuals Discordant for GVHD After Allogeneic Hematopoietic Stem Cell Transplant
The purpose of this study is to examine the gut bacteria, levels of peripheral blood
inflammation markers, and symptoms in patients with and without chronic graft-versus-host
disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The
hypothesis is that individuals with cGVHD will have lower levels of microbial diversity,
higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels
of symptoms than individuals without cGVHD.
inflammation markers, and symptoms in patients with and without chronic graft-versus-host
disease (cGVHD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). The
hypothesis is that individuals with cGVHD will have lower levels of microbial diversity,
higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels
of symptoms than individuals without cGVHD.
This study will recruit 40 (20 with cGVHD and 20 without cGVHD) adults from the Bone Marrow
Transplant Program at University of Florida Health Shands Cancer Hospital. After signing
informed consent, participants will fill out questionnaires and have a blood sample collected
from a vein in the arm. Participants will be given a stool collection kit with instruction
and will return the sample via the mail. Data will be collected and securely stored in a
system used by the cancer center for research. Descriptive statistics will be used to report
individual, clinical factors, and symptoms.
Knowledge gained from this study will provide preliminary data for future longitudinal
studies to examine biological pathways for the development, severity and/or duration of cGVHD
and symptom outcomes in individuals following allo-HSCT impacting quality of life.
Transplant Program at University of Florida Health Shands Cancer Hospital. After signing
informed consent, participants will fill out questionnaires and have a blood sample collected
from a vein in the arm. Participants will be given a stool collection kit with instruction
and will return the sample via the mail. Data will be collected and securely stored in a
system used by the cancer center for research. Descriptive statistics will be used to report
individual, clinical factors, and symptoms.
Knowledge gained from this study will provide preliminary data for future longitudinal
studies to examine biological pathways for the development, severity and/or duration of cGVHD
and symptom outcomes in individuals following allo-HSCT impacting quality of life.
Inclusion Criteria:
- Group 1: Adults (> 18 years of age) within 3 months to 3 years of receiving allogeneic
hematopoietic stem cell transplant (allo-HSCT) diagnosed with cGVHD;
- Group 2: Adults (> 18 years of age) within 3 months to 3 years of receiving allo-HSCT
without a diagnosis of cGVHD; and
- All participants must be able and willing to complete paper and pencil questionnaires,
provide a blood and stool sample, and be able to give informed consent.
Exclusion Criteria:
- Diagnosed with a significant secondary inflammatory disease such as multiple
sclerosis, Crohn's disease, rheumatoid arthritis or secondary cancer;
- History of a major psychological disorder requiring psychotropic medications or
initiation of antidepressants within 30 days of enrollment;
- Incarcerated or pregnant; or
- Any other condition that in the opinion of the principal investigator (PI) may
compromise study participation will not be eligible for participation in this study.
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