Stem Cell Transplant ComplicationsNCT04623424
Intestinal Microbiota in Stem Cell Transplant Transplant Admission
An observational study of Stem Cell Transplant Complications, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- intestinal microbiota
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 3 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stem cell transplant patients
Who may be able to join
- Patients aged 18-80 years
- patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
shatha farhan, 313-916-5002, sfarhan1@hfhs.org
About this study
Official title: 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.
Read the 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:
- 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
- Conditions
- Stem Cell Transplant Complications
- Being tested
- intestinal microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal microbiotaDiagnostic test
Stoll samples will be tested for different bacteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbiome
Measured: Up to 6 months post stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start3 Nov 2020
- Primary completion3 Nov 2028 (estimated)
- Study completion3 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shatha Farhan, Henry Ford Health System
- Investigators
- shatha farhan, Principal investigator, Henry Ford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623424
- Sponsor's protocol ID
- 14270
- Status last verified
- Feb 2026
- First submitted
- 3 Nov 2020
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission
- ClinicalTrials.gov ID
- NCT04623424
- Acronym / sponsor ID
- 14270
- Conditions
- Stem Cell Transplant Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 3 Nov 2028 (estimated)
- Study completion
- 3 Nov 2028 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stem cell transplant patients
Key inclusion criteria (2 listed)
- Patients aged 18-80 years
- patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intestinal microbiotaStoll samples will be tested for different bacteria | Diagnostic test | – |
Primary outcome
Changes in microbiome
Time frame: Up to 6 months post stem cell transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
shatha farhan principal investigator
Henry Ford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shatha farhan, MD (313 916 5002, SFARHAN1@HFHS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbiome (time frame: Up to 6 months post stem cell transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.