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NCT Number: NCT04623424

Intestinal Microbiota in Stem Cell Transplant 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.

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Key information

Conditions

Stem Cell Transplant Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

shatha farhan

CONTACT

[email protected]

313-916-5002

About this study

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:

  • preconditioning
  • at day 0 (stem cell infusion)
  • once in the period of day + 7-10 post SCT
  • once first day or second day of BMT OPD clinic visit
  • once if they develop >=grade I GVHD
  • once at time of recovery from GVHD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

intestinal microbiota

Diagnostic Test

Stoll samples will be tested for different bacteria

Primary outcomes

  1. Changes in microbiome

    Time frame: Up to 6 months post stem cell transplant

Study contacts

Contact information is provided by the study sponsor or research team.

shatha farhan, MD

CONTACT

[email protected]

313 916 5002

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2020
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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