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Looking for participantsPhase2

Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial

Sponsor: Imperial College London

NCT ID: NCT06355583

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
EBX-102 (drug), Placebo (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
EBX-102 — drug: EBX-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 — drug: The capsules contain inactive ingredients microcrystalline cellulose and magnesium stearate.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
50
Started
2024-05-01
Last checked
2025-04

Plain English Summary

What is this study?

  • • Testing a new treatment for acute lymphoblastic leukaemia
  • • Phase2 - 50 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with acute lymphoblastic leukaemia

Where?

  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust
  • • Leeds - Leeds Teaching Hospital NHS Trust
  • • London - University College London Hospitals NHS Trust
  • • London - Kings College NHS Foundation Trust
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Acute Lymphoblastic LeukaemiaAcute Leukemia of Ambiguous LineageChronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeAcute Myeloid Leukemia

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

ABL1 positivehave a negative

Treatment history

Treatments you must have had:

  • ✓ completed minimum of two cycles of intensive chemotherapy
  • ✓ received broad-spectrum antibiotics within 3 months

What the study is looking for

  • ✓Patients in first complete remission (CR1) or second complete remission (CR2) including complete remission with...
  • ✓Secondary leukaemia (defined as previous history of MDS, antecedent haematological disease or drug treatment exposure)...
  • ✓Patients must have completed minimum of two cycles of intensive drug treatment prior to trial enrolment (Appendix 1)
  • ✓Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment
  • ✓Patients must be considered suitable/fit to undergo allogeneic hematopoietic cell transplantation (HCT) as...

Who cannot take part

  • ✗Patients with contraindications to receiving allogeneic HCT.
  • ✗Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative...
  • ✗Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the...
  • ✗Patients with kidney or liver impairment as clinically judged by the Local Investigator.
  • ✗Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV).
See the full criteria
Inclusion Criteria: 1. \- 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 Philadelphia or BCR:ABL1 positive chronic myeloid leukaemia (CML) in blast phase defined by the presence of ≥ 20% blasts in blood or bone marrow who have achieved second chronic phase with \< 5% blasts (Appendix 2). 2. Patients must have completed minimum of two cycles of intensive chemotherapy prior to trial enrolment (Appendix 1) 3. Patients must have received broad-spectrum antibiotics within 3 months prior to trial enrolment 4. Patients must be considered suitable/fit to undergo allogeneic hematopoietic cell transplantation (HCT) as clinically judged by the Local investigator 5. Patients with an Karnofsky performance status score 60 or above (Appendix 3) 6. Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must use appropriate, highly effective, contraception from the point of commencing therapy until 6 months after treatment 7. Patients have given written informed consent 8. Patients willing and able to comply with scheduled study visits and laboratory tests Exclusion Criteria: 1. Patients with contraindications to receiving allogeneic HCT. 2. Female patients who are pregnant or breastfeeding. All women of childbearing potential must have a negative pregnancy test before commencing treatment. 3. Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period. 4. Patients with renal or hepatic impairment as clinically judged by the Local Investigator. 5. Patients with active infection, HIV-positive or chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV). 6. Patients with a concurrent active malignancy or a prior malignancy, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ, incidental histologic finding of prostate cancer (T1a or T1b using the tumour, node, metastasis (TNM) clinical staging system), previous MDS, CMML, Myeloproliferative neoplasms (MPN) resulting in secondary AML. Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated with curative intent \< 5 years previously will not be allowed. 7. Swallowing difficulties that may preclude safe use of IMT capsules. 8. Administration of IMT within 3 months prior to enrolment (probiotic administration prior to enrolment is allowed but should be recorded at screening). 9. Patients taking probiotics after enrolment to the trial. 10. Gastrointestinal disorders and diseases, including delayed gastric emptying, coeliac disease, cystic fibrosis, inflammatory bowel disease, irritable bowel syndrome, chronic diarrhoea, and colonic perforation or fistula. 11. Any autoimmune disease requiring, or that may require, systemic treatment with steroids and/or other immunosuppressants/immunomodulators. 12. Significant bleeding disorder (ALL, AML, AL of ambiguous lineage, MDS, CMML, and CML satisfying inclusion criteria are not excluded). 13. Anaphylactic food allergy. 14. Requirement for vasopressors. 15. Valvular heart disease or known structural defects of the heart. 16. Known severe allergy to capsule components.

Where Is This Study? (8 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2WB, United Kingdom

Recruiting
Site contact (verified)
Francesca KinsellaPrincipal Investigator
Senior Haematology Research Sister01213714351HaematologyCancerResearch@uhb.nhs.uk

Leeds Teaching Hospital NHS Trust

Leeds LS9 7TF, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Principal Investigator01132068561anjum.khan@nhs.net

University College London Hospitals NHS Trust

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Panagiotis KottaridisPrincipal Investigator

Kings College NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Pramila KrishnamurthyPrincipal Investigator
Principal Investigatorp.krishnamurthy@nhs.net

Imperial College Healthcare NHS Trust

London W12 0NN, United Kingdom

Recruiting
Site contact (verified)
Senior Research Operations Manager02037048452Eleni.Vourvou@nhs.net

Royal Mardsen Hostpital

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Emma NicholsonPrincipal Investigator
Haemato-Oncology Department0208915 6187Emma.Nicholson@rmh.nhs.uk

Manchester University NHS Foundation Trust

Manchester M13 9WL, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)

Manchester University NHS Trust

Manchester M13 9WL, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Clinical Trials Coordinator

Sponsor contact

CONTACT

+442075943767 mast-trial@imperial.ac.uk

Julian Marchesi

Sponsor contact

CONTACT

02033126197 j.marchesi@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-04