Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic Graft-Versus-Host Disease

This group will have questionnaires, clinical data, a blood sample and a stool sample collected to be compared with the other group.

Questionnaires

Intervention Type OTHER

Both groups will have questionnaires collected and compared.

Blood Sample

Intervention Type OTHER

Both groups will have a blood sample collected and compared.

Stool Sample

Intervention Type OTHER

Both groups will have a stool sample collected and compared.

Clinical data

Intervention Type OTHER

Both groups will have clinical data collected and compared.

No Chronic Graft-Versus-Host Disease

This group will have questionnaires, clinical data, a blood sample and a stool sample collected to be compared with the other group.

Questionnaires

Intervention Type OTHER

Both groups will have questionnaires collected and compared.

Blood Sample

Intervention Type OTHER

Both groups will have a blood sample collected and compared.

Stool Sample

Intervention Type OTHER

Both groups will have a stool sample collected and compared.

Clinical data

Intervention Type OTHER

Both groups will have clinical data collected and compared.

Interventions

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Questionnaires

Both groups will have questionnaires collected and compared.

Intervention Type OTHER

Blood Sample

Both groups will have a blood sample collected and compared.

Intervention Type OTHER

Stool Sample

Both groups will have a stool sample collected and compared.

Intervention Type OTHER

Clinical data

Both groups will have clinical data collected and compared.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No