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.
- Patients aged 18 years and over with a morphological documented diagnosis of ALL, acute myeloid leukemia (AML), AL of ambiguous lineage, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and CML in blast phase (Appendix 2) who are deemed fit for allogenic HCT with one of the following disease characteristics: ALL, AML, AL of ambiguous lineage
Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with incomplete blood count recovery with < 5% blasts (Appendix 2)
Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or chemotherapy exposure) in CR1 or CR2 defined as < 5% blasts (Appendix 2) MDS and CMML
Patients with advanced or high risk MDS with an International Prognostic Scoring System (IPSS-M) moderate high or higher including intermediate or high risk CMML who have < 5% blasts at the time of randomisation (Appendix 2) CML in blast phase
Patients with contraindications to receiving allogeneic HCT.
Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment.
Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period.
Patients with renal or hepatic impairment as clinically judged by the Local Investigator.
Parallel
EBX-102
DrugEBX-102 is a white size 0 gastro-resistant hydroxypropyl methylcellulose (HPMC) capsule containing communities of dried, intestinal microorganisms extracted from rigorously screened pooled human stool samples obtained from volunteer accredited donors.
Placebo
DrugThe capsules contain inactive ingredients microcrystalline cellulose and magnesium stearate.
Change in gut microbiota diversity using Inverse Simpsons Index
Ecological metric to measure diversity in the gut microbiome in samples collected at two time points. It considers both the number of species present (richness) and their relative abundance (evenness). The Inverse index scale ranges from 0-1 with higher ranges indicating higher diversity.
Gut Microbiome Diversity - Alpha diversity
Measured via changes in Chao-1 , Shannon index and Faith's PD to estimate the richness and functional composition across all timepoints
Alpha Diversity - Chao1 Index
A non-parametric method for estimating Species Richness: referring to the total number of different species present in the gut microbiome, particularly useful for accounting for undetected species.points
Alpha Diversity - Shannon Index
An ecological metric used to measure which combines both, Species Richness: referring to the total number of different species present in the gut microbiome. Species Evenness: this indicates how evenly the species are distributed. A higher index value implies higher evenness and richness.
Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD)
An ecological metric used to measure, Species Richness: referring to the total number of different species present in the gut microbiome. Faiths PD also uses the phylogenetic tree of the identified species to measure the total evolutionary distance. A higher Faith's PD value indicates a wider range of evolutionary diversity
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