RecruitingPHASE2INTERVENTIONAL

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

This research trial, called MAST, is for people with certain blood cancers who are going to have a stem cell transplant. We want to see if taking special capsules, called EBX-102 or 'intestinal microbiota transplant' (IMT), can help restore healthy gut bacteria. Our gut bugs, or 'microbiota', are really important for our overall health, especially when facing cancer treatments. We're comparing these IMT capsules to a dummy capsule (placebo) to understand if they improve how well people feel, reduce infections, and help with recovery after transplant. We'll also look at how diverse the gut bacteria become. Participants will take either the IMT or placebo capsules about two weeks before their transplant and provide samples and answer questionnaires during their regular check-ups.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Imperial College London

Enrolment target

Start

01 May 2024

Estimated completion

01 May 2027

Acute Lymphoblastic Leukaemia Acute Leukemia of Ambiguous Lineage Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome Acute Myeloid Leukemia

What is this study about?

When you have conditions like blood cancer and are preparing for a stem cell transplant, your immune system can be severely affected, and this can also disrupt the healthy balance of bacteria in your gut. A healthy gut microbiome, which is the collection of all the tiny living things in your intestines, plays a big part in keeping you well and fighting off infections. Cancer treatments, especially chemotherapy, can unfortunately harm these helpful gut bacteria.

The MAST trial aims to investigate whether giving a special treatment called 'intestinal microbiota transplant' (IMT) can help bring back a healthier balance of gut bacteria in people just before they have their stem cell transplant. This IMT treatment comes in capsules that contain carefully prepared healthy gut bacteria. We believe that by creating a more balanced gut environment, we might be able to reduce some of the common problems people face after a stem cell transplant, such as infections or other side effects. We want to make sure the IMT capsules are safe and acceptable to patients.

Researchers will be looking closely at several things, including your overall health after the transplant, how often you experience fevers, if you need intensive care, how well you recover, and whether you develop a condition called 'graft-versus-host disease.' By comparing the results from people who receive the IMT capsules with those who receive a dummy capsule (placebo), we hope to learn if this approach can make a positive difference for patients undergoing stem cell transplantation for blood cancers.

Key takeaways

This study focuses on improving gut health before a stem cell transplant for blood cancer.
It tests special healthy bacteria capsules (IMT) against dummy capsules.
Aims to reduce infections and improve recovery after transplant.
Participation involves taking capsules once, plus giving samples and answering questionnaires.
It could offer new ways to support patients undergoing transplant.

Who may be eligible?

This study is looking for adults aged 18 or over who have certain types of blood cancer. These include Acute Lymphoblastic Leukaemia (ALL), Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukaemia (CMML), and Chronic Myeloid Leukaemia (CML) in blast phase, among others. You must be planned to have a stem cell transplant from a donor (allogeneic HCT) and meet specific criteria related to your disease status. For example, some patients need to be in remission, meaning their cancer is not detectable, or have specific types of advanced or high-risk MDS or CMML.

Quick self-check

Are you 18 years old or older?
Do you have a specific type of blood cancer (like ALL, AML, MDS, CMML, or CML in blast phase) and are you planning to have a stem cell transplant from a donor?
Have you already had at least two rounds of strong chemotherapy?
Have you been on broad-spectrum antibiotics within the last three months?
Are you considered fit enough for a stem cell transplant by your doctor?
Do you have a Karnofsky performance status score of 60 or higher (meaning you're mostly able to care for yourself and many activities)?
Are you willing and able to use reliable contraception if you could become pregnant or get someone else pregnant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be asked to do a few things. You'll need to provide stool (poo), urine (wee), and blood samples at your planned study visits. These visits are usually part of your normal follow-up appointments. You will also be asked to complete some questionnaires at certain times, which will help us understand how you're feeling and your experience with the treatment. About two weeks before your stem cell transplant (give or take a few days), you will swallow either the active IMT capsules or dummy placebo capsules once. This is a one-time treatment. The study will then follow your progress during your regular check-ups to see how your gut bacteria change and how you recover.

Potential risks and benefits

Participating in this study might offer the potential benefit of helping to restore your gut bacteria to healthier levels, which could theoretically reduce complications like infections after your stem cell transplant. However, it's important to remember that this is a research study, and we don't yet know for sure if the IMT capsules will have these benefits. There may be risks associated with taking the capsules, although we expect these to be mild, and providing samples might cause minor discomfort. You are completely free to withdraw from the study at any time without affecting your medical care.

Locations (8)

University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom· Recruiting
Leeds Teaching Hospital NHS Trust
Leeds, United Kingdom· Not yet recruiting
University College London Hospitals NHS Trust
London, United Kingdom· Recruiting
Kings College NHS Foundation Trust
London, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
London, United Kingdom· Recruiting
Royal Mardsen Hostpital
London, United Kingdom· Recruiting
Manchester University NHS Foundation Trust
Manchester, United Kingdom· Not yet recruiting
Manchester University NHS Trust
Manchester, United Kingdom· Recruiting

Common questions

What is 'intestinal microbiota transplant' (IMT)?

IMT is a treatment that uses healthy gut bacteria, usually in capsule form, to try and restore a better balance of bacteria in your intestines.

What is a 'placebo'?

A placebo is a dummy capsule that looks exactly like the active treatment but doesn't contain any medicine. We use it to fairly compare the effects of the active treatment.

Why is my gut bacteria important?

Your gut bacteria play a big role in your overall health, including helping your immune system and preventing infections, which is especially important during cancer treatment.

Will I know if I'm getting the active capsules or the placebo?

No, this is a 'blinded' study, meaning neither you nor your care team will know whether you receive the active IMT capsules or the placebo. This helps ensure the study results are accurate.

What type of stem cell transplant is this for?

This study is for patients receiving an 'allogeneic hematopoietic cell transplant' (HCT), which means you're receiving stem cells from a donor, not your own previously collected cells.

How to find out more

Clinical Trials Coordinator

mast-trial@imperial.ac.uk +442075943767 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.