Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT

Completed

Conditions studied: Graft vs Host Disease, Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation

In brief

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.

Key facts

Study ID

NCT02398708

Run by

University of Florida

People needed

38

Starts

2015-05-01

Expected to finish

2016-04-01

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UF Health Cancer Hospital — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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