Comparison of Gut Microbiota, Inflammation and Symptoms Following Allogeneic HSCT

NCT02398708 | Completed

• 4 other identifiers: IRB201400992UF-BMT-cGVHD-101ID00023244OCR14208
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Plasma levels of inflammatory markers (cytokines and CRP) of individuals post allogeneic HSCT

  Cytokines will be analyzed using a multiplex assay by Millipore Company. Compared to the traditional enzyme-linked immunosorbant assays (ELISA), the multiplex is comparable and more sensitive to lower concentration levels of cytokines than the ELISA. One laser identifies a specific bead and another laser identifies the reported antibody associated with the bead-bound cytokine. One hundred beads for each of the 17 cytokines in every sample are assayed and a mean cytokine binding for the sample is determined. The manufacturer reports that the assay accurately measures cytokine values in a range of 1-2500pg/ml. Serum CRP will be measured using the ALPCO's (American Laboratory Products Company) high-sensitivity CRP assay which uses latex particle enhanced immunoturbidimetry for quantitative CRP determination.

  Day 1

• Diversity and levels of fecal microbes of individuals post allogeneic HSCT

  Fecal microbial DNA will be extracted from between 50-200 mg of fecal material. The 16S ribosomal gene (V4 region) of each sample will be amplified using a barcoding system to allow multiplexing with the Illumina MiSeq system. We will use UNIFRAC algorithm to evaluate the null hypothesis that the structure of the microbial community is insensitive to cGVHD and symptoms of cGVHD. Differences in taxa are implicated by our high throughput sequencing methods will be confirmed by other techniques including culturing (where appropriate) and qPCR with taxa-specific primers.

  Day 1

• Behavioral responses (symptoms) of individuals post allogeneic HSCT

  Day 1

Secondary Outcomes (8)

• Health Promoting Lifestyle Profile II (HPLPII)

  Day 1

• Perceived Stress Scale (PSS)

  Day 1

• Brief Pain Inventory (BPI)

  Day 1

• Hospital Anxiety and Depression Scale (HADS)

  Day 1

• Brief Fatigue Inventory (BFI)

  Day 1

Study Arms (2)

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.

Other: Questionnaires; Other: Blood Sample; Other: Stool Sample; Other: Clinical data

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.

Other: Questionnaires; Other: Blood Sample; Other: Stool Sample; Other: Clinical data

Interventions

Questionnaires OTHER

Both groups will have questionnaires collected and compared.

Chronic Graft-Versus-Host Disease; No Chronic Graft-Versus-Host Disease

Blood Sample OTHER

Both groups will have a blood sample collected and compared.

Chronic Graft-Versus-Host Disease; No Chronic Graft-Versus-Host Disease

Stool Sample OTHER

Both groups will have a stool sample collected and compared.

Chronic Graft-Versus-Host Disease; No Chronic Graft-Versus-Host Disease

Clinical data OTHER

Both groups will have clinical data collected and compared.

Chronic Graft-Versus-Host Disease; No Chronic Graft-Versus-Host Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

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.

Sponsors & Collaborators

• University of Florida: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

UF Health Cancer Hospital

Gainesville, Florida, 32608, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and stool specimens

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Debra Lynch Kelly, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 25, 2019

Record last verified: 2019-01

Locations

US (1)