Status:
RECRUITING
Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia
Lead Sponsor:
Tata Memorial Centre
Conditions:
Acute Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
* Goal: This study is a randomized phase II interventional study. The purpose of this study is to see if addition of oral rifaximin tablets during allogeneic stem cell transplant can improve the quali...
Detailed Description
The gut microbiome plays a significant role in modulating the immune re-constitution post allogeneic stem cell transplant (ASCT). Low gut microbial diversity has been consistently associated with poor...
Eligibility Criteria
Inclusion
- Adults with acute leukemia undergoing allogeneic stem cell transplant.
- ECOG performance status 0, 1 or 2.
- Adequate Liver function
Exclusion
- Known hypersensitivity to rifaximin or other rifampicin antimicrobial agents
- Current or past history of inflammatory bowel disease
- History of major bowel resection or presence of colostomy.
- Ongoing Verapamil, ketoconazole or itraconazole.
Key Trial Info
Start Date :
August 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 2 2027
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT06058572
Start Date
August 2 2024
End Date
August 2 2027
Last Update
July 31 2025
Active Locations (1)
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1
Actrec Tmc
Navi Mumbai, Maharashtra, India, 410210