Comparison of the Fecal Microbiome, Peripheral Inflammatory Markers, and Symptoms in Individuals Discordant for GVHD After Allogeneic Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Behavioral responses (symptoms) of individuals post allogeneic HSCT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Behavioral responses (symptoms) of individuals post allogeneic HSCT
时间窗: Day 1
Plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
时间窗: Day 1
Cytokines will be analyzed using a multiplex assay by Millipore Company. Compared to the traditional enzyme-linked immunosorbant assays (ELISA), the multiplex is comparable and more sensitive to lower concentration levels of cytokines than the ELISA. One laser identifies a specific bead and another laser identifies the reported antibody associated with the bead-bound cytokine. One hundred beads for each of the 17 cytokines in every sample are assayed and a mean cytokine binding for the sample is determined. The manufacturer reports that the assay accurately measures cytokine values in a range of 1-2500pg/ml. Serum CRP will be measured using the ALPCO's (American Laboratory Products Company) high-sensitivity CRP assay which uses latex particle enhanced immunoturbidimetry for quantitative CRP determination.
Diversity and levels of fecal microbes of individuals post allogeneic HSCT
时间窗: Day 1
Fecal microbial DNA will be extracted from between 50-200 mg of fecal material. The 16S ribosomal gene (V4 region) of each sample will be amplified using a barcoding system to allow multiplexing with the Illumina MiSeq system. We will use UNIFRAC algorithm to evaluate the null hypothesis that the structure of the microbial community is insensitive to cGVHD and symptoms of cGVHD. Differences in taxa are implicated by our high throughput sequencing methods will be confirmed by other techniques including culturing (where appropriate) and qPCR with taxa-specific primers.
次要结局
- Perceived Stress Scale (PSS)(Day 1)
- Lee Symptom Bother Scale(Day 1)
- Brief Pain Inventory (BPI)(Day 1)
- Hospital Anxiety and Depression Scale (HADS)(Day 1)
- Brief Fatigue Inventory (BFI)(Day 1)
- Health Promoting Lifestyle Profile II (HPLPII)(Day 1)
- Memorial Symptom Assessment Scale (MSAS-SF)(Day 1)
- Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT)(Day 1)