NCT04623424

Intestinal Microbiota in Stem Cell Transplant Transplant Admission

Intestinal Microbiota Alteration by Antibiotics Used During Stem Cell Transplant Admission

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 255 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stem Cell Transplant Complications

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	intestinal microbiota	Stoll samples will be tested for different bacteria

Timeline

• Start date: 2020-11-03
• Primary completion: 2028-11-03
• Completion: 2028-11-03
• First posted: 2020-11-10
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States