Intestinal Microbiota in Stem Cell Transplant Transplant Admission

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04623424
• Collaborator: (none)
• Enrollment: 255
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications	Diagnostic Test: intestinal microbiota

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 Design

• Study Type: Observational
• Anticipated Enrollment: 255 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission
• Actual Study Start Date: Nov 3, 2020
• Anticipated Primary Completion Date: Nov 3, 2023
• Anticipated Study Completion Date: Nov 3, 2024

Outcome Measures

Primary Outcome Measures

1. Changes in microbiome [Up to 6 months post stem cell transplant]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients aged 18-80 years

• patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Health System	Detroit	Michigan	United States	48202

Sponsors and Collaborators

• Henry Ford Health System

Investigators

• Principal Investigator: shatha farhan, Henry Ford

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shatha Farhan, Clinical Assistant Professor, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT04623424
• Other Study ID Numbers: 14270
• First Posted: Nov 10, 2020
• Last Update Posted: Dec 27, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Dec 27, 2021