Clinical Trial

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

Study acronym: MAST
Recruiting Phase 2
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Record status
This record was last updated April 17, 2025 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant. The main questions it aims to answer are: * Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires * Changes in gut microbiome diversity across all timepoints * Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured. Participants will be asked at their routine follow up visits to, * Provide stool, urine and blood samples at the scheduled study visits * Complete questionnaires at selected visits * Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days) Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-04-04.
Status change: Not Yet Recruiting → Recruiting 2025-04-14
Trial Details
NCT Number NCT06355583
Lead Sponsor Imperial College London
Conditions Acute Lymphoblastic Leukaemia, Acute Leukemia of Ambiguous Lineage, Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome, Acute Myeloid Leukemia
Enrollment 50 participants
Start Date 2024-05-01
Primary Completion 2026-02-01 (estimated)
Study Completion 2027-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-17