Goethe University Frankfurt
Verified
Frankfurt, Germany
Not yet recruitingEnterobacter infection
Study on the Effectiveness of Intestifix, Colistin Sulfate, and Vancomycin for Patients with Infections from Multidrug-Resistant Enterobacteriaceae
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying infections caused by multidrug-resistant Enterobacteriaceae, a group of bacteria that are resistant to many antibiotics. The study will test a treatment approach that combines antibiotics with a special type of therapy called fecal microbiota transfer (FMT). FMT involves using healthy bacteria from a donor's stool to help restore balance in the gut of the person receiving the treatment. The main goal of the study is to see if this combination can effectively remove the resistant bacteria from the gut by day 30 of the treatment.
The study will use a product called INTESTIFIX 001, which is a capsule containing the FMT, and two antibiotics, Colistin Sulfate and Vancomycin. Participants will receive these treatments in different dosing regimens to find the most effective way to clear the resistant bacteria. The study will also include a comparison with a placebo to evaluate the effectiveness of the treatment. The treatment period will last for up to four weeks, and participants will be monitored for any changes in their health and the presence of the resistant bacteria.
Throughout the study, researchers will assess the safety and tolerability of the treatments by observing any side effects or new medical conditions that may arise. They will also examine changes in the gut bacteria and fungi over time, comparing the results at different points, such as day 0, 4, 12, 30, and 90. The study aims to provide valuable information on how well the treatment works and its impact on the overall health of participants, including the rate of infections and hospitalizations up to 90 days after starting the treatment.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Patients must be 18 years or older.
- Patients must have a positive test showing they carry a type of bacteria called multidrug-resistant Enterobacteriaceae (MDR-E). This test should be done with a rectal swab or stool sample within 14 days before joining the study.
- Patients should be at risk of infection from the bacteria they carry. This means they have had at least two infections in the last 6 months or three infections in the last 12 months. Alternatively, patients can join if they have a weakened immune system due to one of the following conditions:
- They have had a solid organ transplant and are taking two or more drugs to suppress their immune system.
- They have received CAR-T-cell therapy or a stem cell transplant within the last 100 days to 2 years.
- They have a moderate or severe primary immunodeficiency, which is a condition where the immune system does not work properly (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome).
- They are taking medications that weaken the immune system, such as:
- Corticosteroids like prednisone at a dose of 20 mg or more daily for at least 14 days within the last 30 days.
- Other drugs that suppress the immune system, including those used for cancer treatment or to prevent organ rejection.
- They have chronic kidney disease and have been on dialysis for at least 6 months.
- They have HIV with a low CD4+ cell count (less than 200 cells per mm³) in the last 6 months.
Who cannot join the trial?
3 criteria
- Patients with **infections** caused by **multidrug-resistant Enterobacteriaceae** cannot participate. This means if you have an infection that does not respond to many antibiotics, you are not eligible.
- Patients who are not within the specified **age range** cannot participate. The study is open to certain age groups only.
- Patients who are part of a **vulnerable population** are not eligible. This refers to groups of people who might need special protection or care.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Universitaetsklinikum Heidelberg AöR
VerifiedHeidelberg, GermanyUniversitaetsklinikum Muenster AöR
VerifiedMunster, Germany
Trial locations
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Investigated drugs
Frozen Encapsulated Fecal Microbiota Transfer (FMT) is a therapy that involves taking healthy bacteria from the stool of a donor and putting it into capsules. These capsules are then swallowed by the patient. The goal of this therapy is to introduce good bacteria into the patient's gut to help get rid of harmful bacteria that are resistant to many antibiotics. This process is known as decolonization, and it aims to restore a healthy balance of bacteria in the gut.
What is already known about the treatment
Frozen Encapsulated Fecal Microbiota Transfer (FMT) Products – This medication is administered orally in the form of capsules containing frozen fecal microbiota. It is currently being studied in clinical trials to determine its effectiveness and safety in treating infections caused by multidrug-resistant Enterobacteriaceae. The main therapeutic use of this treatment is to help remove these resistant bacteria from the body. At the molecular level, the mechanism involves introducing healthy bacteria into the gut to outcompete and displace harmful, drug-resistant bacteria. This treatment falls under the pharmacological classification of microbiota-based therapies.
Investigated diseases
Infections with multidrug-resistant Enterobacteriaceae – These infections are caused by a group of bacteria known as Enterobacteriaceae, which have developed resistance to multiple antibiotics. The bacteria can colonize the intestines and may spread to other parts of the body, leading to infections. These infections can occur in various body sites, including the urinary tract, bloodstream, and respiratory system. The bacteria can be transmitted through direct contact with infected individuals or contaminated surfaces. The progression of the disease depends on the site of infection and the individual's immune response. The bacteria's resistance to antibiotics makes these infections challenging to manage and control.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519748-34-00Protocol codeRESET-MDREstimated enrolment76 patientsSponsorGoethe University Frankfurt
sourced from the EU Clinical Trials Register and site verification
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