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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (8 UK sites)
University Hospitals Birmingham NHS Foundation Trust
Birmingham B15 2WB, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds LS9 7TF, United Kingdom
University College London Hospitals NHS Trust
London NW1 2BU, United Kingdom
Kings College NHS Foundation Trust
London SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust
London W12 0NN, United Kingdom
Royal Mardsen Hostpital
London SW3 6JJ, United Kingdom
Manchester University NHS Foundation Trust
Manchester M13 9WL, United Kingdom
Manchester University NHS Trust
Manchester M13 9WL, United Kingdom
How to Get in Touch
Clinical Trials Coordinator
Sponsor contactCONTACT
Julian Marchesi
Sponsor contactCONTACT
