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

ady Tata Memorial Trust0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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).

•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.

发起方

ady Tata Memorial Trust