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Effectiveness and Safety of INTESTIFIX in Removing Vancomycin‑Resistant Enterococci Colonization in Immunocompromised Patients – drug combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

People whose immune systems are weakened can sometimes carry vancomycin-resistant enterococci in their intestines without feeling sick. This bacteria can spread to other parts of the body and cause serious infections, especially in patients whose bodies cannot fight germs well. The study looks at whether giving a special preparation of healthy gut bacteria, called fecal microbiota transfer, can help remove this harmful bacteria from the intestine.

Participants are randomly given either the gut‑bacteria preparation or a placebo. The treatment is given in one or two doses, and stool samples are collected about a month, three months and six months later to see if the bacteria are gone. Throughout the study doctors check for any side effects and monitor overall health, including how the patients feel and any changes in quality of life.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment

    On the first day after joining the study, you will provide a stool sample and a rectal swab. these specimens are used to confirm the presence of vancomycin‑resistant enterococci.

    Blood tests and a quality‑of‑life questionnaire (eq‑5d‑5l) will also be completed to record your health status before any treatment.

  2. Step 2

    Randomization

    Based on the baseline results, you will be randomly assigned to receive either intestifix 001 or a matching placebo. you will also be assigned to a single‑dose or two‑dose schedule, as determined by the study protocol.

  3. Step 3

    Bowel preparation

    Before each dose of the study medication, you will take the oral laxative moviprep. the preparation is supplied as a 100 g oral solution that you dissolve in water and drink as instructed.

    The purpose of moviprep is to clean the bowel so that the study medication can reach the intestine effectively.

  4. Step 4

    First dose of study medication

    After completing the bowel preparation, you will swallow one intestifix 001 capsule containing 30 u (units) of the active substance, or one matching placebo capsule, by mouth.

    The capsule is taken once on the scheduled day and does not require any additional dosing on that day.

  5. Step 5

    Second dose (if assigned to two‑dose group)

    If you are in the two‑dose group, a second dose of the same capsule (30 u) will be taken on a later day, following the same bowel‑preparation procedure with moviprep.

    The exact interval between the first and second dose is specified by the study team.

  6. Step 6

    Day 30 follow‑up

    Around day 30, you will provide a stool sample and a rectal swab on two consecutive days. both samples must test negative for vancomycin‑resistant enterococci to be considered a successful decolonization.

    You will also complete the eq‑5d‑5l questionnaire again and answer any questions about side effects or new health problems.

  7. Step 7

    Day 90 follow‑up

    The same collection of stool sample and rectal swab on two consecutive days will be repeated at day 90, along with another quality‑of‑life questionnaire.

    Any adverse events that occurred since the previous visit will be recorded.

  8. Step 8

    Day 180 follow‑up and study end

    The final set of stool and rectal swab collections will be performed on two consecutive days at day 180 to assess long‑term decolonization.

    Final safety assessments, including blood tests and a last quality‑of‑life questionnaire, will be completed.

    After these assessments, the study participation is concluded.

Who can join the trial?

7 criteria

  • You are an adult, meaning you are 18 years old or older.
  • You have been shown to have vancomycin‑resistant enterococci (VRE) living in your intestines, proven by a stool (fecal) test that grew the bacteria within one week before joining the study. VRE is a type of bacteria that does not respond to the antibiotic vancomycin.
  • You are receiving cancer‑related treatments that increase the chance of a VRE infection, such as:
    • a stem cell transplant – either using your own cells (autologous) or a donor’s cells (allogeneic) planned within the next 4‑8 weeks, or
    • CAR‑T cell therapy planned within the next 4‑8 weeks, or
    • current therapy with immune‑checkpoint inhibitors or bispecific antibodies, with at least one more dose expected within the next 8 weeks.
    • You have signed a written informed consent form and a data‑protection declaration before any study procedures begin. Informed consent means you understand what the study involves and agree to take part.
    • You are willing and able to follow the study’s visits, tests, and instructions.

Who cannot join the trial?

16 criteria

  • You cannot be taking antibiotics or preventive antibiotics (except co‑trimoxazole) in the 30 days before the first study visit.
  • You cannot be staying in an Intensive Care Unit (ICU), a special hospital area for very sick patients.
  • You cannot be pregnant or breastfeeding.
  • Women who could become pregnant must agree to use a very reliable birth control method (less than 1% chance of failure per year) from the screening visit until at least 30 days after the last study medication, or must agree not to have heterosexual sex during the study if this fits their lifestyle.
  • Any other health problem that the doctor thinks could affect the study results or your safety.
  • People who are placed in a care facility by a court order or legal decision.
  • People who work at the study location, work for the company running the study, are part of the research team, or are close family of the lead doctor.
  • People who are not legally able to give consent or cannot understand what the study involves.
  • Planning to start any other antimicrobial medicines (other than the study drug, called IMP) to try to remove VRE during the study.
  • If you cannot swallow 30 FMT capsules (capsules containing the study product) in 5 hours on two separate days.
  • If you have active inflammatory bowel disease (such as ulcerative colitis or Crohn’s disease) that required new or changed immunosuppressive medication in the last three months.
  • Severe inflammation of the intestines from any other reason.
  • Advanced chronic heart failure, classified as stage III or IV on the NYHA scale (a system that measures how much heart failure limits daily activities).
  • Any hole, blockage, severe slowdown, or inability to empty the stomach (gastrointestinal perforation, obstruction, ileus, or retention of gastric contents).
  • Being part of another clinical trial that involves a treatment.
  • Having a known hypersensitivity or allergy to any ingredient in the study medication.
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Investigated drugs

  • INTESTIFIX

    is the investigational product being tested in the study. It is taken by mouth in capsule form and is intended to help remove harmful bacteria (VRE) from the gut of patients with weakened immune systems. The trial is looking at how well this capsule works to clear the infection and whether it is safe for patients.

  • MOVIPREP

    is a background medication used in the trial. It is an oral solution that contains vitamins and salts, as well as a substance that draws water into the intestines to cause a gentle bowel cleanse. This preparation helps clear the intestine before the main treatment, making it easier to assess the effect of the investigational product.

What is already known about the treatment

  • INTESTIFIX

    This medication is supplied as an oral capsule that is swallowed whole, delivering a dose of 30 U of live bacterial material. It is currently an investigational product with limited data in the medical literature, being studied mainly in clinical trials for gut microbiome therapy. The main therapeutic aim is to help remove vancomycin‑resistant enterococci (VRE) from the intestines of immunocompromised patients. It works by introducing beneficial microbes that compete with VRE and restore a healthier balance of gut bacteria, and it is classified as a live biotherapeutic (probiotic) product.

  • MOVIPREP

    This medication comes as a powder that is dissolved in water to create an oral solution taken by drinking, providing a total of 100 g of the mixture per dose. It is an approved, widely used osmotic laxative that appears in standard medical references under ATC code A06AD. Its primary use is to clean the bowel before procedures or to treat constipation, and it acts by drawing water into the intestine to soften stool and promote bowel movements. The active ingredients work together to increase intestinal fluid through osmotic pressure, and the product is classified as an osmotic laxative.

Investigated diseases

Vancomycin‑resistant Enterococcus colonization - This condition occurs when bacteria that are resistant to the antibiotic vancomycin live in the intestines without causing immediate illness. The bacteria can multiply and spread within the gut over time. As the number of resistant organisms increases, they may become harder for the body’s natural defenses to control. The colonization can persist for weeks or months if the balance of gut microbes does not change. Over time, the presence of these bacteria can lead to a higher chance of them moving to other parts of the body. The situation often remains stable unless external factors alter the gut environment.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525632-41-00Protocol codeTMP-19012026-1Estimated enrolment42 patientsSponsorFraunhofer Institute For Translational Medicine And Pharmacology ITMP

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