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Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Sponsor: Imperial College London
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-05-01
Completion Date
2027-05-01
Last Updated
2025-04-17
Healthy Volunteers
No
Conditions
Interventions
EBX-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.
Placebo
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