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NCT04623424 Clinical Trial

Intestinal Microbiota in Stem Cell Transplant Transplant Admission

Stem Cell Transplant Complications Clinical Trial

Official title:
Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04623424
Other study ID # 14270
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 3, 2020
Est. completion date November 3, 2026

Study information
Verified date January 2024
Source Henry Ford Health System
Contact shatha farhan, MD
Phone 313 916 5002
Email SFARHAN1@HFHS.ORG
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this prospective study, the primary objective will be to investigate the association between the use of antibiotics administered during the admission period of Stem cell transplant (SCT) and the rate of overall change in microbiota composition across adjacent samples in time.

Description:

Early preclinical studies suggested that intestinal microflora contribute to aGVHD and may be relapse. There is increasing evidence that use of antibiotics may have a detrimental impact on intestinal microbiota composition and, consequently, the outcome of SCT.However, effect on different antibiotic prophylaxis regimens and broad-spectrum antibiotics used during transplant and the intestinal microbiota composition and hence adverse outcomes are not known. Stool samples will be collected from patients who are undergoing SCT at: 1. preconditioning 2. at day 0 (stem cell infusion) 3. once in the period of day + 7-10 post SCT 4. once first day or second day of BMT OPD clinic visit 5. once if they develop >=grade I GVHD 6. once at time of recovery from GVHD

Recruitment information / eligibility
Status Recruiting
Enrollment 255
Est. completion date November 3, 2026
Est. primary completion date November 3, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients aged 18-80 years - patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure

Study Design

Related Conditions & MeSH terms

  • Stem Cell Transplant Complications

Intervention

Diagnostic Test:
• intestinal microbiota
Stoll samples will be tested for different bacteria

Locations
Country Name City State
United States Henry Ford Health System Detroit Michigan

Sponsors (1)
Lead Sponsor Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in microbiome Up to 6 months post stem cell transplant
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