Actively Recruiting
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Led by Imperial College London · Updated on 2025-04-17
50
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and over with documented diagnosis of ALL, AML, AL of ambiguous lineage, MDS, CMML, or CML in blast phase, fit for allogeneic stem cell transplantation
- Patients with specified disease states including first or second complete remission with less than 5% blasts
- Patients with secondary leukemia in remission with less than 5% blasts
- Patients with advanced or high risk MDS or CMML with less than 5% blasts
- Patients with CML in blast phase who achieved second chronic phase with less than 5% blasts
- Completed minimum of two cycles of intensive chemotherapy prior to enrolment
- Received broad-spectrum antibiotics within 3 months prior to enrolment
- Considered suitable/fit for allogeneic hematopoietic cell transplantation by local investigator
- Karnofsky performance status score 60 or above
- Females and males of reproductive potential must use effective contraception from therapy start until 6 months after treatment
- Provided written informed consent
- Willing and able to comply with scheduled study visits and laboratory tests
You will not qualify if you...
- Contraindications to receiving allogeneic hematopoietic cell transplantation
- Female patients who are pregnant or breastfeeding; women of childbearing potential must have a negative pregnancy test before treatment
- Adults of reproductive potential unwilling to use effective contraception during required period
- Renal or hepatic impairment as judged clinically
- Active infections including HIV, chronic active hepatitis B or C
- Concurrent active malignancy or prior malignancy except certain specified types or treated cancers over 5 years prior
- Swallowing difficulties preventing safe use of IMT capsules
- Received IMT within 3 months prior to enrolment; probiotic use prior to enrolment must be recorded
- Use of probiotics after enrolment
- Gastrointestinal disorders including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhea, colonic perforation or fistula
- Autoimmune diseases requiring or potentially requiring systemic steroids or immunosuppressants
- Significant bleeding disorders except those included in inclusion
- Anaphylactic food allergy
- Requirement for vasopressors
- Valvular heart disease or known structural heart defects
- Known severe allergy to capsule components
AI-Screening
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Trial Site Locations
Total: 8 locations
1
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom, B15 2WB
Actively Recruiting
2
Leeds Teaching Hospital NHS Trust
Leeds, England, United Kingdom, LS9 7TF
Not Yet Recruiting
3
University College London Hospitals NHS Trust
London, England, United Kingdom, NW1 2BU
Actively Recruiting
4
Kings College NHS Foundation Trust
London, England, United Kingdom, SE5 9RS
Actively Recruiting
5
Imperial College Healthcare NHS Trust
London, England, United Kingdom, W12 0NN
Actively Recruiting
6
Royal Mardsen Hostpital
London, United Kingdom, SW3 6JJ
Actively Recruiting
7
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
8
Manchester University NHS Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
C
Clinical Trials Coordinator
CONTACT
J
Julian Marchesi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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