RecruitingPhase 2NCT06058572

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

Randomized Trial to Study the Effect of Rifaximin on Gut Microbiome Diversity Post Allogeneic Stem Cell Transplant in Acute Leukemia.


Sponsor

Tata Memorial Centre

Enrollment

166 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

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 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. Carbapenems, colistin, tigecycline, ceftazidime avibactum and ceftriaxone-sulbactam EDTA) in first 6 months post BMT. * d. To determine the impact of rifaximin induced gut manipulation on immune reconstitution, T cell repertoire post-transplant and cytokine profile. * Exploratory objective: To use single cell transcriptomics (SCT) to identify immune cell profile in gut biopsies post allogeneic stem cell transplant whenever biopsy is done, to correlate the impact of microbiome on gut immunity. * Intervention: Tab Rifaximin 200 mg will be given orally twice daily from day -8 to day +60 of allogeneic stem cell transplant in acute leukemia patients. This will be in addition to standard of care post-transplant treatment. * Comparator Agent: Standard of care treatment including standard anti GVHD measures, antibiotic support and transfusions as needed.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether an antibiotic called rifaximin can protect the gut bacteria of patients with leukemia who are receiving a stem cell transplant. Stem cell transplants can disrupt the natural balance of gut bacteria, and this trial wants to see if rifaximin helps prevent that. **You may be eligible if...** - You are an adult with acute leukemia - You are scheduled to receive a stem cell transplant from a donor (allogeneic transplant) - Your liver is functioning adequately - Your general health is reasonable (ECOG score 0, 1, or 2) **You may NOT be eligible if...** - You have a known allergy to rifaximin or similar antibiotics (like rifampin) - You have a history of inflammatory bowel disease (such as Crohn's or ulcerative colitis) - You have had major bowel surgery or have a colostomy - You are currently taking verapamil, ketoconazole, or itraconazole Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRifaximin 200Mg Tab

Drug rifaximin 200 mg tablet form orally twice daily (with or without food) from day-8 of transplant to day + 60 of transplant

PROCEDUREallogenic hematopoietic stem cell transplantation

Control arm will undergo allogenic hematopoietic stem cell transplantation as standard of care


Locations(1)

Actrec Tmc

Navi Mumbai, Maharashtra, India

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NCT06058572


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