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

Sponsor
Imperial College London
Study ID
NCT06355583
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Apr 9, 2024
Start date
May 1, 2024
Status verified
Apr 2025
Primary completion
Feb 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo
    Patients randomised on to the placebo arm will swallow 10 placebo capsules once at the second study visit approximately 2 weeks before the stem cell transplantation. The capsules contain inactive ingredients (microcrystalline cellulose and magnesium stearate) and will have the same appearance, weight, and packaging weight to the IMT capsules in the treatment arm to maintain treatment blinding.
  • Active Comparator: EBX-102-02
    Patients randomised on to the Treatment arm will swallow 10 capsules once at the second study visit approximately 2 weeks before the stem cell transplantation. Each capsule will contain 1x10\^6 - 1x10\^9 colony forming units (CFU)/g of viable microorganisms and will have the same appearance, weight and packaging weight to the placebo capsules in the treatment arm to maintain treatment blinding.

Primary Outcome Measure

Change in gut microbiota diversity using Inverse Simpsons Index [ Time Frame: Screening - up to 42 before stem cell transplantation (HCT) and Assessment 5 - Day 28(+/-3) post stem cell transplantation (HCT) ]

Central Contacts

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