A trial looking at the effectiveness of a treatment made from donated stool samples to see if gut bacteria can be increased in patients having a transplant for blood cancer.

Background and study aims
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 an effective treatment for recurrent Clostridioides difficile infection (rCDI) due to 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 transplants.
Who can participate?
Adult patients with blood cancer
What does the study involve?
Up to 50 eligible patients will be recruited for 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.
Patients will be asked to report side effects in a patient diary for 7 days after receiving treatment and be given a contact number for the study doctor or nurse to call for support or guidance. Each day there will be 7 yes/no tick questions for patients to answer to maintain simplicity and to keep the completion time short. The purpose of the patient diary is to help patients monitor any potential side effects and for the investigators to collect clinical data on the IMP's safety and tolerability.
Patients will attend 11 visits for the study. The patients will be inpatients at their local hospital 28 days prior to stem cell transplant which will account for 4 of the study visits. To reduce the remaining burden other visits will coincide with those of standard care and patients who attend study visits will be eligible to claim compensation for travel expenses.
Blood, urine and stool samples will be collected for 10 of the study visits. The amount of blood collected will be kept to a minimum at each visit i.e. equivalent to a teaspoon (5ml). Blood collected for research will be analysed in St Mary's Hospital to gather metabolic data. For stool samples, patients will be given the option of providing these within 24 hours of a study visit via the use of relevant sample collection materials and a travel bag for transportation.
Patients will complete a quality of life questionnaire at 4 of the 11 study visits, with the possibility that some of the questions may cause discomfort or distress and this will be offset by support from appropriately trained staff delegated to perform study activities at local sites. All questionnaires for the study, including the dietary questionnaire, can be completed at the study visit and therefore should not create an additional time burden for patients outside the local site setting.