MAST
Research type
Research Study
Full title
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) trial
IRAS ID
1006971
Contact name
Lee Webber
Contact email
Sponsor organisation
Imperial College London
Eudract number
2022-003617-10
Research summary
There are thousands of bacteria and other microbes that live in the intestines (also referred to as the gut microbiota) that play an important role in keeping the body healthy, examples of this include supporting the immune system, digestion and the uptake of nutrients. Past research has shown that a lower number of microbes present in the gut can reduce its supportive role in the body and as a result cause immune and gut related complications.
Intestinal microbiota transplantation (IMT) has been established as effective treatment for recurrent Clostridioides difficile infection (rCDI) due its ability to restore the number and diversity of gut microbes to a healthy level reducing the chance of reoccurrence.
Patients with blood cancers are more prone to having weaker immune systems from anti-cancer treatments such as chemotherapy. A lower immune system also increases the risk of patients developing an infection which will require antibiotic treatment.
Patients with blood cancers also receive many courses of antibiotics for bacterial infections. Antibiotics reduce the number of gut microbes present and previous research has shown a link between reduced gut microbiota and poorer survival outcomes in patients receiving stem cell transplants. Therefore, the aim of the MAST study is to investigate the ability to restore gut microbiota to healthier levels and to assess the clinical outcomes in patients with blood cancers scheduled to have stem cell transplant.
Up to 50 eligible patients will be recruited onto the study from 6 participating UK hospitals. Participants will be randomised to 1 of the 2 treatment groups to receive either IMT by capsule (group 1) or placebo (group 2). Participants will be followed up for 24 months.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0105
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion