NCT04623424

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Nov 2020Nov 2028

First Submitted

Initial submission to the registry

November 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2028

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

November 3, 2020

Last Update Submit

February 23, 2026

Conditions

Stem Cell Transplant Complications

Outcome Measures

Primary Outcomes (1)

  • Changes in microbiome

    Up to 6 months post stem cell transplant

Interventions

intestinal microbiotaDIAGNOSTIC_TEST

Stoll samples will be tested for different bacteria

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stem cell transplant patients

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Interventions

Gastrointestinal Microbiome

Intervention Hierarchy (Ancestors)

MicrobiotaMicrobiological PhenomenaBiotaBiodiversityEcosystemEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • shatha farhan

    Henry Ford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shatha farhan, MD

CONTACT

313 916 5002SFARHAN1@HFHS.ORG

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 10, 2020

Study Start

November 3, 2020

Primary Completion (Estimated)

November 3, 2028

Study Completion (Estimated)

November 3, 2028

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

US(1)