Effect of Rifaximin on gut bacterial flora post Stem Cell Transplant in patients with Acute Leukemia.

Phase 2

Conditions: Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

Registration Number: CTRI/2023/07/054803

Lead Sponsor: ady Tata Memorial Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

a.Patients with acute leukemia and planned for aHSCT.

b.Patients with age more than 18 years ( > 18 years).

c.Patients who give written informed consent.

d.Underlying hematologic malignancy in which aHSCT is indicated.

e.ECOG performance status 0, 1 or 2 (on day of enrolment).

f.Adequate Liver function test with serum SGOT/AST and SGPT/ALT < 3.0 times upper normal limit (ULN) and total bilirubin < 2.0 times ULN (on day of enrolment).

Exclusion Criteria

a.Known hypersensitivity to rifaximin or other rifampicin antimicrobial agents

b.Patients on therapy with antibiotics for bacterial or fungal infections on day of enrolment (Except for azole prophylaxis for fungal infections, acyclovir prophylaxis for herpes and cotrimoxazole prophylaxis for pneumocystis jerovecii infections, which are permissible).

c.Patients with current or past history of inflammatory bowel disease

d.Patients with history of major bowel resection or patients with colostomy.

e.Use of rifampicin or rifaximin in last 1 month before enrolment.

f.Any serious medical condition or psychiatric illness that would prevent the subject from signing the informed consent form or in opinion of the investigator make the patient unfit for enrolment in the trial.

g.Patients on the following P-glycoprotein inhibitors at time of enrolment: Verapamil, ketoconazole and itraconazole will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the impact of rifaximin on gut microbial alpha <br/ ><br>diversity as measured by inverse simpson index (ISI) and compare it with controls.Timepoint: 15 days post transplant

Secondary Outcome Measures