MAST study
Key Information
Chief Investigator: Prof Julian Marchesi and Dr Jiri Pavlu
ICTU collaboration: Operations; Statistics; Database.
Email: mast-trial@imperial.ac.uk
Trial registration: TBC
Status: Set-up
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) trial
Thousands of bacteria and other microbes in the intestines (gut microbiota) play an important role in keeping the body healthy. Research has shown that a lower number reduces their supportive role, causing immune and gut-related complications.
Patients with haematological (blood) cancer are prone to having a weak immune system and at increased risk of infection e.g. as a result of chemotherapy. These patients receive many courses of antibiotics which reduce gut microbiota diversity. Research has shown a link between reduced diversity and poorer survival outcomes in this population.
Intestinal microbiota transplantation (IMT) has been established as an effective treatment for recurrent Clostridioides difficile (C. diff) infection, due to its ability to restore gut microbiota diversity to a healthy level and reduce the chance of reinfection.
The aim of the MAST study is to investigate whether the IMT capsule treatment EBX-102 restores gut microbiota diversity in patients due to have a stem cell transplant as part of standard treatment for blood cancer. A range of secondary objectives encompassing clinical, safety and quality of life outcomes will also be assessed.
Up to 50 eligible participants will be recruited onto the study from six participating UK hospitals.
Participants will be randomised to receive either EBX-102 or matched placebo.
Participants will be followed up for 12 months.