RecruitingPhase 2NCT06355583

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


Sponsor

Imperial College London

Enrollment

50 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether transplanting healthy gut bacteria (intestinal microbiota transplant) before a bone marrow transplant (stem cell transplant) can reduce serious complications like dangerous infections and graft-versus-host disease in blood cancer patients. **You may be eligible if...** - You are 18 or older with a diagnosed blood cancer — including leukemia (ALL, AML), myelodysplastic syndrome (MDS), CMML, or CML in blast phase - Your cancer is in remission (less than 5% cancer cells) or meets other defined criteria - You are considered medically fit to undergo a bone marrow transplant - You have completed at least two rounds of intensive chemotherapy - You have received broad-spectrum antibiotics within the past 3 months **You may NOT be eligible if...** - Your cancer does not meet the remission criteria - You are not considered suitable for a bone marrow transplant - You have not completed at least two rounds of intensive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEBX-102

EBX-102 is a white size 0 gastro-resistant hydroxypropyl methylcellulose (HPMC) capsule containing communities of dried, intestinal microorganisms extracted from rigorously screened pooled human stool samples obtained from volunteer accredited donors.

DRUGPlacebo

The capsules contain inactive ingredients microcrystalline cellulose and magnesium stearate.


Locations(8)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom

Leeds Teaching Hospital NHS Trust

Leeds, England, United Kingdom

University College London Hospitals NHS Trust

London, England, United Kingdom

Kings College NHS Foundation Trust

London, England, United Kingdom

Imperial College Healthcare NHS Trust

London, England, United Kingdom

Royal Mardsen Hostpital

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Manchester University NHS Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06355583


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