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

NCT06058572 | Recruiting Phase 2 DMC

• 1 other identifier: 900872
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Leukemia

Keywords

Rifaximin; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• Impact of rifaximin on gut microbial diversity.

  Gut microbial diversity as measured by inverse Simpson index (ISI) on stool samples on day 14 post transplant in Rifaximin arm and in controls.

  14 days post transplant

Secondary Outcomes (4)

• Non relapse mortality

  1 year post transplant

• Incidence of severe (grade III/IV) acute graft versus host disease

  1 year post transplant

• Impact of gut decontamination with rifaximin on incidence of multidrug resistant sepsis post transplant.

  6 months post transplant

• Impact of rifaximin induced gut manipulation on immune reconstitution

  1 year post transplant

Study Arms (2)

Rifaxmin +aHSCT

EXPERIMENTAL

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

Drug: Rifaximin 200Mg Tab

aHSCT alone

ACTIVE COMPARATOR

control arm will underwent allogenic hematopoietic stem cell transplantation procedure as per standard of care

Procedure: allogenic hematopoietic stem cell transplantation

Interventions

Rifaximin 200Mg Tab DRUG

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

Rifaxmin +aHSCT

allogenic hematopoietic stem cell transplantation PROCEDURE

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

aHSCT alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with acute leukemia undergoing allogeneic stem cell transplant.
• ECOG performance status 0, 1 or 2.
• Adequate Liver function

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Actrec Tmc

Navi Mumbai, Maharashtra, 410210, India

RECRUITING

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Dr. Anant Gokarn, Gokarn

  Advanced Centre for Treatment, Research and Education in Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Anant Gokarn, DM

CONTACT

+91-02268735000; anantgokarn@gmail.com

Dr.Sumeet Mirgh, DM

CONTACT

+91-02268735000; drsumeetmirgh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional Arm : Tab Rifaximin 200 mg along with allogeneic stem cell transplant Standard Arm : Allogeneic stem cell transplant alone (with no anti-microbial prophylaxis)

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: August 2, 2024
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): August 2, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)