Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT

University of Florida

Status

Completed

Conditions

Graft Versus Host Disease

Peripheral Blood Stem Cell Transplantation

Graft vs Host Disease

Hematopoietic Stem Cell Transplantation

Treatments

Other: Blood Sample

Other: Clinical data

Other: Questionnaires

Other: Stool Sample

Study type

Observational

Funder types

Other

Identifiers

NCT02398708

ID00023244 (Other Grant/Funding Number)

OCR14208 (Other Identifier)

UF-BMT-cGVHD-101 (Other Identifier)

IRB201400992

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.