NCT02398708

Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT

Comparison of the Fecal Microbiome, Peripheral Inflammatory Markers, and Symptoms in Individuals Discordant for GVHD After Allogeneic Hematopoietic Stem Cell Transplant

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft vs Host Disease
• Graft Versus Host Disease
• Hematopoietic Stem Cell Transplantation
• Peripheral Blood Stem Cell Transplantation

Interventions

Type	Name	Description
OTHER	Questionnaires	Both groups will have questionnaires collected and compared.
OTHER	Blood Sample	Both groups will have a blood sample collected and compared.
OTHER	Stool Sample	Both groups will have a stool sample collected and compared.
OTHER	Clinical data	Both groups will have clinical data collected and compared.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-03-25
• Last updated: 2019-01-25

Locations

1 site across 1 country: United States