Clinical trial NCT02398708: Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT
Official title: Comparison of the Fecal Microbiome, Peripheral Inflammatory Markers, and Symptoms in Individuals Discordant for GVHD After Allogeneic Hematopoietic Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft vs Host Disease
Graft Versus Host Disease
Hematopoietic Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation
Keywords: Hematopoietic Stem Cell Transplantation
Graft versus Host Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2015-03-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 allo-Hematopoietic Stem Cell Transplantation (HSCT) recipients with chronic graft-versus-host disease (cGVHD) and 20 allo-Hematopoietic Stem Cell Transplantation (HSCT) recipients without chronic graft-versus-host disease (cGVHD)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT
timeFrame: Day 1
measure: Diversity and levels of fecal microbes of individuals post allogeneic HSCT
timeFrame: Day 1
measure: Behavioral responses (symptoms) of individuals post allogeneic HSCT
timeFrame: Day 1
Secondary outcomes:
measure: Health Promoting Lifestyle Profile II (HPLPII)
timeFrame: Day 1
measure: Perceived Stress Scale (PSS)
timeFrame: Day 1
measure: Brief Pain Inventory (BPI)
timeFrame: Day 1
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Day 1
measure: Brief Fatigue Inventory (BFI)
timeFrame: Day 1
measure: Lee Symptom Bother Scale
timeFrame: Day 1
measure: Memorial Symptom Assessment Scale (MSAS-SF)
timeFrame: Day 1
measure: Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT)
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Debra Lynch Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: