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Effect of Rifaximin on Gut Bacterial Flora Post Stem Cell Transplant in Patients With Acute Leukemia

RecruitingPhase 2Ages 18 Years - 70 YearsAllTata Memorial Centre
NCT06058572 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

* 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 quality of gut microbiome and reduce chances of death, infections and graft versus host disease (GVHD) post-transplant. * The study objectives are as follows: * Primary Objective: To determine the impact of rifaximin on gut microbial diversity and compare it with controls. * Secondary Objectives: a. To determine non-relapse mortality at 1-year post transplant in patients who receive peri-transplant transplant rifaximin and compare it with controls. * b. To compare the incidence of severe GVHD in patients who receive peri-transplant rifaximin with the controls. * c. To determine impact of gut decontamination with rifaximin on incidence of MDR sepsis and usage of higher antibiotics (e.g. Carbapenem

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults with acute leukemia undergoing allogeneic stem cell transplant. * ECOG performance status 0, 1 or 2. * Adequate Liver function Exclusion Criteria: * 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.
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What it tests

  • Rifaximin 200Mg Tab
  • allogenic hematopoietic stem cell transplantation
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Where

1 site
Actrec Tmc
Navi Mumbai, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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