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Brief Title: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Official Title: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Study ID: NCT06355583
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Jiri Pavlu
Affiliation: Imperial College London
Role: PRINCIPAL_INVESTIGATOR