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RECRUITING
NCT06355583
PHASE2

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

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-05-01

Completion Date

2027-05-01

Last Updated

2025-04-17

Healthy Volunteers

No

Interventions

DRUG

EBX-102

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.

DRUG

Placebo

The capsules contain inactive ingredients microcrystalline cellulose and magnesium stearate.

Locations (8)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom

Leeds Teaching Hospital NHS Trust

Leeds, England, United Kingdom

University College London Hospitals NHS Trust

London, England, United Kingdom

Kings College NHS Foundation Trust

London, England, United Kingdom

Imperial College Healthcare NHS Trust

London, England, United Kingdom

Royal Mardsen Hostpital

London, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

Manchester University NHS Trust

Manchester, United Kingdom