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

Launched by TATA MEMORIAL CENTRE · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called rifaximin can help improve gut health in patients with acute leukemia who are undergoing a type of treatment known as allogeneic stem cell transplant. The researchers want to see if taking rifaximin can make the gut bacteria more diverse and healthy, which may lower the risk of serious complications like infections and a condition known as graft versus host disease (GVHD) after the transplant. Participants in the study will take rifaximin in addition to the usual care they receive after the transplant.

To be eligible for this trial, participants must be adults aged 18 years or older who have acute leukemia and are preparing for allogeneic stem cell transplant. They should have a good performance status, meaning they are well enough to participate, and their liver function should be adequate. However, people with a history of certain bowel problems or who are allergic to rifaximin won't be able to join. Throughout the study, participants can expect to take rifaximin twice a day for about two months, and they will be monitored closely for any changes in their gut health and overall recovery. This research aims to find better ways to support patients during and after their treatment.

Gender

ALL

Eligibility criteria

• 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.