protocolSection identificationModule nctId: NCT06355583, orgStudyIdInfo id: C/42/2022, secondaryIdInfos id: 2022-003617-10, type: EUDRACT_NUMBER, briefTitle: Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial, acronym: MAST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Lymphoblastic Leukaemia, conditions: Acute Leukemia of Ambiguous Lineage, conditions: Chronic Myeloid Leukemia, conditions: Chronic Myelomonocytic Leukemia, conditions: Myelodysplastic Syndrome, conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: EBX-102, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in gut microbiota diversity using Inverse Simpsons Index, secondaryOutcomes measure: Gut Microbiome Diversity - Alpha diversity, secondaryOutcomes measure: Alpha Diversity - Chao1 Index, secondaryOutcomes measure: Alpha Diversity - Shannon Index, secondaryOutcomes measure: Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD), secondaryOutcomes measure: Beta Diversity - Aitchison Distance, secondaryOutcomes measure: Gut Microbiome Taxonomic Composition, secondaryOutcomes measure: Markers of general health - ITU Admission, secondaryOutcomes measure: Quality of life EQ-5D-5L, secondaryOutcomes measure: Quality of Life EORTC-QLQ-C30, secondaryOutcomes measure: Infective Haematological Outcomes - Fever Occurrence, secondaryOutcomes measure: Infective Haematological Outcomes - Fever CTCAE Grade, secondaryOutcomes measure: Infective Haematological Outcomes - Infection, secondaryOutcomes measure: Infective Haematological Outcomes - Multi drug Resistant Bacterial Colonisation (MDROs), secondaryOutcomes measure: Infective Haematological Outcomes - Antibiotic Use, secondaryOutcomes measure: Markers of General Health - Severity of Mucositis, secondaryOutcomes measure: Markers of General Health -Occurrence of Severe Acute Kidney Injury (AKI), secondaryOutcomes measure: Markers of General Health - Occurrence of Severe liver dysfunction, secondaryOutcomes measure: Markers of general health - Use of Parenteral Nutrition, secondaryOutcomes measure: Neutrophil and platelet engraftment data, secondaryOutcomes measure: Recovery of T-cell Chimaerisms,, secondaryOutcomes measure: Haematological Outcomes - Non-relapsed mortality, secondaryOutcomes measure: Haematological Outcomes - Occurrence Graft vs Host Disease, secondaryOutcomes measure: Haematological Outcomes - Severity of graft vs Host Disease, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Graft-versus disease-free relapse-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Birmingham NHS Foundation Trust, city: Birmingham, state: England, zip: B15 2WB, country: United Kingdom, contacts name: Senior Haematology Research Sister, role: CONTACT, phone: 01213714351, email: HaematologyCancerResearch@uhb.nhs.uk, contacts name: Francesca Kinsella, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.48142, lon: -1.89983, locations facility: Leeds Teaching Hospital NHS Trust, city: Leeds, state: England, zip: LS9 7TF, country: United Kingdom, contacts name: Principal Investigator, role: CONTACT, phone: 01132068561, email: anjum.khan@nhs.net, geoPoint lat: 53.79648, lon: -1.54785, locations facility: University College London Hospitals NHS Trust, city: London, state: England, zip: NW1 2BU, country: United Kingdom, contacts name: BMT Trials, role: CONTACT, email: uclh.bmttrials@nhs.net, contacts name: Panagiotis Kottaridis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Kings College NHS Foundation Trust, city: London, state: England, zip: SE5 9RS, country: United Kingdom, contacts name: Principal Investigator, role: CONTACT, email: p.krishnamurthy@nhs.net, contacts name: Pramila Krishnamurthy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, city: London, state: England, zip: W12 0NN, country: United Kingdom, contacts name: Senior Research Operations Manager, role: CONTACT, phone: 02037048452, email: Eleni.Vourvou@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Mardsen Hostpital, city: London, zip: SW3 6JJ, country: United Kingdom, contacts name: Haemato-Oncology Department, role: CONTACT, phone: 0208915 6187, email: Emma.Nicholson@rmh.nhs.uk, contacts name: Emma Nicholson, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False