Intestinal Microbiota in Stem Cell Transplant Transplant Admission
- Conditions
- Stem Cell Transplant Complications
- Registration Number
- NCT04623424
- Lead Sponsor
- Henry Ford Health System
- 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 255
- Patients aged 18-80 years
- patients undergoing allogenic or autologous SCT for malignant hematological conditions or bone marrow failure
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in microbiome Up to 6 months post stem cell transplant
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Henry Ford Health System
🇺🇸Detroit, Michigan, United States