None listed
Conditions
Brief summary
The HSCT-BIOME study aims to promote gut microbiota health prior to conditioning chemotherapy and promote its stability/recovery after HSCT using encapsuled, lyophilised faecal microbiota transplantation (FMT). Who is it for? You may be eligible for this study if you are a male or female over the age of 18 and have been diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT. Study details Participants in this study will be randomised to receive either encapsulated faecal microbiota transplantation (FMT) or placebo; each given as 2 courses of 36 capsules. The first course starts before chemotherapy, aiming to boost gut microbiota health. You will be given the second course after HSCT, once your immune system has recovered. Participants' bowel function and symptom burden will be assessed daily for 3 weeks after HSCT. Other clinical data, including how long you stay in hospital and the use of other medications to control side effects, will also be collected. Any adverse event will be constantly monitored during intervention until 30 days post FMT. It is hoped that findings from this study will show FMT is safe and effective at reducing HSCT complications.
Interventions
Encapsulated faecal microbiota transplantation (FMT) administered over two courses (each course = 36 capsules, containing 25g stool).
- FMT#1: 6 capsules a day for 6 days starting 1 week before conditioning
chemotherapy
- FMT#2: 6 capsules a day for 2 days then 2 capsules (ONCE DAILY) a day
until course is complete (total 14 days)
Adherence will be reviewed by FMT capsule return and participant diary.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult (greater or equal to 18 years of age) 2. Diagnosed with multiple myeloma, leukaemia, lymphoma or another haematological malignancy to be treated with auto-HSCT 3. Scheduled to receive conditioning chemotherapy (+/- total body irradiation) prior to auto-HSCT 4. Able to provide written informed consent and follow all clinical trial related procedures (translator to be provided for people of culturally and linguistically diverse (CALD) backgrounds)
Exclusion criteria
1. Pre-existing gastrointestinal disease including Crohn’s disease, ulcerative colitis 2. Unable to swallow capsules 3. Pregnancy 4. Nut allergy or anaphylactic food allergy 5. Uncontrolled vomiting or oral mucositis that may impact swallowing (determined by participant) ** 6. Fever (body temp >37.8oC) ** ** Eligibility criteria to be reviewed before post- HSCT FMT intervention
Outcome results
None listed