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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Adults with acute leukemia undergoing allogeneic stem cell transplant.

• ECOG performance status 0, 1 or 2.

• Adequate Liver function

Locations
Other Locations
India
Actrec Tmc
RECRUITING
Navi Mumbai
Contact Information
Primary
Dr. Anant Gokarn, DM
anantgokarn@gmail.com
+91-02268735000
Backup
Dr.Sumeet Mirgh, DM
drsumeetmirgh@gmail.com
+91-02268735000
Time Frame
Start Date: 2024-08-02
Estimated Completion Date: 2027-08-02
Participants
Target number of participants: 166
Treatments
Experimental: Rifaxmin +aHSCT
drug rifaximin 200 mg tablet form orally twice daily (with or without food) from day-8 of transplant to day + 60 of transplant
Active_comparator: aHSCT alone
control arm will underwent allogenic hematopoietic stem cell transplantation procedure as per standard of care
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov