RecruitingPHASE2INTERVENTIONAL

Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

The PHOEBUS trial aims to check if a new treatment, called MaaT033, can improve survival rates for patients having a specific type of stem cell transplant. This treatment involves using healthy gut bacteria, similar to a 'gut flora transplant', to help prevent common problems that can happen after such transplants. Patients aged 50 and over with a blood cancer will be randomly given either MaaT033 or a dummy treatment (placebo). The main goal is to see if MaaT033 can reduce transplant-related complications, helping people recover better and live longer. This is a Phase II study, meaning it's still an early stage of testing this new approach.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

MaaT Pharma

Enrolment target

387

Start

31 Oct 2023

Estimated completion

15 Feb 2027

Transplant Complication

What is this study about?

When someone has a stem cell transplant for conditions like blood cancer, their own bone marrow is replaced with healthy cells from a donor. This is a life-saving treatment, but it can also cause serious side effects and complications. One area doctors are studying is the 'gut microbiome' – the trillions of tiny bacteria and other microbes that live in our intestines. These microbes play a big role in our health, including our immune system.

After a stem cell transplant, especially when strong medicines are used, the balance of these gut microbes can be severely disrupted. This imbalance is thought to contribute to various post-transplant problems, including a weakened immune system, infections, and a condition called graft-versus-host disease (GvHD), where the new donor cells attack the patient's own body. The PHOEBUS trial is exploring if restoring a healthy balance of gut bacteria can prevent these complications.

The MaaT033 treatment being tested uses specially prepared healthy gut bacteria from donors. The idea is that by introducing these beneficial microbes, patients can maintain a healthier gut environment, which in turn might help their immune system recover and reduce the risk of serious complications, ultimately improving their chances of a successful transplant and a better quality of life. This study hopes to understand if this approach can make a real difference for patients.

Key takeaways

The study tests a new treatment (MaaT033) using healthy gut bacteria.
It aims to prevent problems after a stem cell transplant.
Participants must be aged 50 or over and having a certain type of transplant.
It's a Phase II study, meaning it's an early stage of testing.
You will either receive the treatment or a dummy medicine (placebo).

Who may be eligible?

This study is looking for volunteers aged 50 or older who have certain blood cancers and are planning to have a stem cell transplant. You would need to be well enough to undergo the transplant, with good overall health as measured by things like your walking ability and how well your organs are working. You would also need to have received strong antibiotics in the last three months.

There are several reasons why someone might not be able to join. For example, if your specific transplant plan involves certain very strong chemotherapy treatments, or if you're receiving a specially treated stem cell donation. Also, if you have certain existing health problems like serious heart, lung, or kidney issues, or a history of specific gut diseases, you wouldn't be able to take part. Being pregnant would also prevent you from joining.

It's important to discuss all your health conditions and planned treatments with your doctor to see if this study could be an option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 50 years old or older?
Are you planning to have a stem cell transplant for a blood cancer?
Have you been unwell recently and received strong antibiotics in the last 3 months?
Are you generally well and active, with your 'Karnofsky index' at 70% or higher?
Do you have good kidney, liver, heart, and lung function?
Are you not pregnant and do not have certain chronic gut conditions?

Answer every question to see your result.

What does participation involve?

If you join the PHOEBUS trial, you'll be randomly assigned to receive either the active treatment (MaaT033) or a dummy treatment (placebo) – neither you nor your doctors will know which one you receive. Both are given by mouth. You'll continue with your planned stem cell transplant and all the usual care that comes with it.

The study involves regular check-ups and assessments, which will be scheduled around your transplant and recovery. These will include blood tests, physical examinations, and possibly tests to look at your gut bacteria. The doctors will closely monitor your health for any transplant-related complications. The total duration of your participation in the study from receiving the treatment until the final follow-up will be decided by the research team, but studies like this usually involve monitoring for several months or even a year or more after the transplant. You can stop participating at any time.

Potential risks and benefits

Potential benefits of taking part could include receiving a new treatment that might help prevent serious complications after your stem cell transplant, potentially improving your recovery and overall survival. However, there's no guarantee that you will benefit, as this is still an experimental treatment. As with any medical study, there are potential risks, though the treatment is designed to be as safe as possible. These might include side effects from the study treatment itself, or from the extra tests and visits required. All known possible risks will be fully explained to you before you decide to join. Remember, taking part is voluntary, and you are free to withdraw from the study at any time without affecting your ongoing medical care.

Locations (54)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitair Ziekenhuis Antwerpen
Verified postcode
Antwerp, Belgium· Recruiting
AZ Sint - Jan Brugge
Verified postcode
Bruges, Belgium· Recruiting
Institut Jules Bordet
Verified postcode
Brussels, Belgium· Recruiting
Universitair Ziekenhuis Brussel
Verified postcode
Brussels, Belgium· Recruiting
Universitair Ziekenhuis Gent
Verified postcode
Ghent, Belgium· Recruiting
Cliniques Universitaires Saint-Luc
Verified postcode
Leuven, Belgium· Recruiting
Algemeen Ziekenhuis Delta - Campus Rumbeke
Verified postcode
Roeselare, Belgium· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
CHU Besançon
Verified postcode
Besançon, France· Recruiting
CHU Caen
Verified postcode
Caen, France· Recruiting
CHU Grenoble
Verified postcode
La Tronche, France· Recruiting
CHRU Lille
Verified postcode
Lille, France· Recruiting

Common questions

What is 'fecal microbiotherapy'?

It's a treatment that involves introducing healthy gut bacteria, usually from a healthy donor, into your digestive system to restore a healthy balance.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real treatment but contains no active medicine. It helps researchers fairly test if the real treatment works.

Why is 'gut bacteria' important after a transplant?

The balance of gut bacteria can be disrupted by transplant treatments, and a healthy balance is thought to be important for your immune system and preventing complications.

Who is funding this study?

This study is sponsored by MaaT Pharma, the company developing the MaaT033 treatment.

Can I still have my regular transplant if I join?

Yes, taking part in this study means you will still receive your planned stem cell transplant and all the usual medical care.

How to find out more

Emilie Plantamura, PharmD, PhD

eplantamura@maat-pharma.com 0033 663590186 Official trial record

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