Rifaximin to improve gut bacteria after allogeneic stem cell transplant for acute leukemia
Official title: Randomized Trial to Study the Effect of Rifaximin on Gut Microbiome Diversity Post Allogeneic Stem Cell Transplant in Acute Leukemia.
Run by Tata Memorial Centre · NCT06058572 · Data updated 2026-11-12
This trial tests whether taking oral rifaximin around the time of an allogeneic stem cell transplant helps preserve healthy gut bacteria and reduces infections, graft‑versus‑host disease, and death in adults with acute leukemia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 166 (estimated) |
| Sponsor | Tata Memorial Centre Academic / other |
| Locations | 1 site (Navi Mumbai, Maharashtra) |
| Status | Recruiting |
| Started | August 2, 2024 |
| Main results expected | August 2, 2027 |
| Study ends | August 2, 2027 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT06058572 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with acute leukemia undergoing allogeneic stem cell transplant who have ECOG performance status 0–2 and adequate liver function, and who do not have contraindications such as rifaximin allergy, inflammatory bowel disease, major bowel resection, colostomy, or interacting medications.
✕Probably not a fit
Patients with active inflammatory bowel disease, prior major bowel resection or colostomy, known hypersensitivity to rifamycins, or those taking contraindicated interacting drugs are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized phase II study comparing oral rifaximin given around the time of allogeneic hematopoietic stem cell transplant with standard care. The trial will measure changes in gut microbial diversity as the primary endpoint and track clinical outcomes including non‑relapse mortality at one year, incidence of severe acute GVHD, multidrug‑resistant sepsis, and use of broad‑spectrum antibiotics over six months. Rifaximin is a locally acting antibiotic thought to clear pathogenic bacteria while preserving beneficial anaerobes, which may help maintain alpha diversity of the gut microbiome. The study is conducted at ACTREC, Tata Memorial Centre in Navi Mumbai with peri‑transplant treatment and scheduled follow‑up and sample collection.
Why it matters
Potential benefit: If successful, rifaximin could help preserve gut microbial diversity and lower rates of severe GVHD, serious infections, and transplant‑related death.
How similar studies have gone: Rifaximin is established for altering the gut microbiome in hepatic disease and small observational reports suggest microbiome preservation may reduce post‑transplant complications, but randomized evidence in allogeneic stem cell transplant is limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Actrec Tmc
Navi Mumbai, Maharashtra, India Recruiting
Study contacts
- Principal investigator: Dr. Anant Gokarn, Gokarn — Advanced Centre for Treatment, Research and Education in Cancer
- Study coordinator: Dr. Anant Gokarn, DM
- Email: anantgokarn@gmail.com
- Phone: +91-02268735000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.