NCT06058572

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

Recruiting now Phase 2 Last updated 31 July 2025

What this trial tests

Phase 2 trial testing Rifaximin 200Mg Tab in Acute Leukemia in 166 participants. Currently enrolling.

Timeline

2 August 2024

Primary endpoint
2 August 2027

2 August 2027

Quick facts

Lead sponsor	Tata Memorial Centre
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	166
Start date	2 August 2024
Primary completion	2 August 2027
Estimated completion	2 August 2027
Sites	1 location across India

Drugs / interventions tested

• Rifaximin 200Mg Tab — full drug profile →
• allogenic hematopoietic stem cell transplantation

Conditions studied

• Acute Leukemia — all drugs for Acute Leukemia →

Sponsor

Tata Memorial Centre — full company profile →

Who can join

Adults 18 to 70, any sex, with Acute Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.