AuthorisedTherapeutic exploratory (Phase II)Interventional

Randomized Controlled Trial Assessing the Effectiveness and Safety of Fecal Microbiota Transfer for VRE Eradication in Immunocompromised Patients (EU CTR, Phase II) – VRE-ex

Vancomycin-resistant enterococci, or VRE, are bacteria that can live harmlessly in the gut but cause dangerous infections in people with weakened immune systems. Because these bugs resist common antibiotics, doctors need new ways to get rid of them. This trial investigates a treatment called faecal microbiota transfer (FMT), using a preparation named INTESTIFIX 001. FMT introduces friendly bacteria from a healthy donor into the patient's gut to help crowd out the stubborn bugs. Participants will be split into two groups by chance: one group receives the real treatment and the other gets an inactive dummy medicine (placebo). Before the treatment, participants take a bowel-cleansing drink called Moviprep. Doctors will track participants for up to six months using stool samples and swabs to see if the bug clears and to ensure the treatment is safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fraunhofer Institute For Translational Medicine And Pharmacology ITMP

Enrolment target

Start

21 Jul 2026

Intestinal colonization with vancomycin-resistant enterococci (VRE)

What is this study about?

Our guts are home to billions of bacteria, most of which help keep us healthy. However, sometimes hard-to-treat bugs can settle there too. One of these is called VRE (vancomycin-resistant enterococci). In healthy people, VRE usually causes no trouble. But in individuals with weakened immune systems, such as people having cancer care, it can cause severe infections that antibiotics struggle to treat.

This study looks at whether a treatment known as faecal microbiota transfer (FMT) can safely clear VRE from the bowel. FMT works like reseeding a lawn: it introduces a mix of healthy bacteria from a carefully checked donor to crowd out the harmful bugs. The trial uses a specially prepared treatment called INTESTIFIX 001 to see if it can reset the gut balance.

Researchers want to find out if giving one or two doses of this treatment works better than a placebo (a dummy treatment). By clearing VRE before it can cause an active illness, doctors hope to protect vulnerable patients from serious infections down the line.

Key takeaways

The study tests whether healthy gut bacteria can clear antibiotic-resistant VRE bugs.
It is designed for adults aged 18 and over who have a weakened immune system.
Participants will receive either the study treatment (INTESTIFIX 001) or a dummy medicine.
Follow-up involves providing stool samples and swabs over about six months.
Taking part is voluntary and will not affect your normal NHS care.

Who may be eligible?

This study is open to adults aged 18 and older of any sex who carry VRE in their gut and have a weakened immune system.

Because this trial focuses on people whose natural defences are lowered, participants will usually be under medical care for underlying conditions such as blood disorders, cancer, or receiving treatments that suppress immunity.

The study team will check your overall health and medical history to make sure taking the bowel preparation and having the gut transfer is safe 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.

I am aged 18 or older.
A doctor has confirmed that I have VRE bacteria in my gut.
I have a weakened immune system (for example, due to cancer or immunosuppressive treatment).
I am willing to drink a bowel-cleansing solution before the procedure.
I can attend regular check-ups and provide stool samples over six months.

Answer every question to see your result.

What does participation involve?

Taking part lasts around six months. Before receiving the study treatment, you will drink a standard bowel preparation liquid (Moviprep) to help clear out the bowel. You will then be randomly assigned (like a coin flip) to receive either the active donor bacteria (INTESTIFIX 001) or an inactive dummy treatment.

You may receive one or two doses. Over the course of the study, you will attend hospital visits and provide regular stool samples and gentle rectal swabs. These checks usually take place around day 30, day 90, and day 180.

The research team will closely monitor your gut health, test whether the VRE bug has cleared, and check for any side effects throughout your time in the trial.

Potential risks and benefits

A potential benefit is that the treatment might remove the VRE bug from your bowel, lowering your future risk of serious infection. It will also help doctors learn how to treat these bugs better in others. However, there is no guarantee the treatment will work for you, and you might receive the dummy medicine. Risks include temporary tummy discomfort, bloating, nausea, or diarrhoea, especially from the bowel-cleansing drink. Because your immune system is weakened, the medical team will watch you very closely for any unexpected infections or reactions. Joining is entirely your choice, and you can leave the study at any time without your regular NHS care being affected.

Locations (1)

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

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Unverified
Germany

Common questions

What is VRE?

VRE stands for vancomycin-resistant enterococci. They are bacteria that can live in the gut and are hard to treat because they do not respond to common antibiotics.

What is faecal microbiota transfer (FMT)?

FMT is a process where healthy, thoroughly screened gut bacteria from a donor are given to a patient to restore a healthy balance in their bowel.

Can I choose whether I get the real treatment or the dummy?

No. A computer randomly assigns you to either the active medicine or the placebo to ensure the study results are fair and unbiased.

Are the donor samples safe?

Yes. Stool donors undergo rigorous health screenings and laboratory tests to ensure their samples do not carry harmful germs or illnesses.

Do I have to pay for the treatment?

No. Clinical trial treatments and required tests are provided free of charge to participants.