Intestinal Microbiota in Stem Cell Transplant Transplant Admission

January 3, 2024 updated by: Shatha Farhan, Henry Ford Health System

Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Estimated)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

stem cell transplant patients

Description

Inclusion Criteria:

  • Patients aged 18-80 years
  • patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in microbiome
Time Frame: Up to 6 months post stem cell transplant
Up to 6 months post stem cell transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Investigators

  • Principal Investigator: shatha farhan, Henry Ford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2020

Primary Completion (Estimated)

November 3, 2025

Study Completion (Estimated)

November 3, 2026

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 14270

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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