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Study of Oral Fecal Microbiota Transplantation in Patients Colonized with Multi-Drug Resistant Bacteria

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What is this trial about?

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

This study focuses on patients who have multidrug-resistant gram-negative bacteria (MDR-GNB) in their digestive system. These bacteria include extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBL-E) and carbapenem-resistant Enterobacteriaceae (CRE), which are difficult to treat with common antibiotics.

The study investigates whether fecal microbiota transplant (FMT) can remove these resistant bacteria from the body. FMT is a treatment that uses healthy gut bacteria from donors to restore balance in the patient's digestive system. The treatment is given in the form of oral capsules that contain processed stool material from healthy donors.

During the study, participants will receive either the fecal microbiota capsules or placebo capsules. The treatment involves taking multiple capsules by mouth over two days. The main goal is to determine if this treatment can eliminate the resistant bacteria from the body when checked approximately one month after treatment.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    You will receive 50 oral capsules that need to be taken in a single day

    The capsules will contain either fecal microbiota transplant (beneficial gut bacteria) or placebo (inactive substance)

    The capsules are double-encapsulated and designed to be taken by mouth

  2. Step 2

    Monitoring period

    Your health status will be monitored for 30 days (plus or minus 10 days) after receiving the capsules

    During this period, medical staff will check if certain bacteria are still present in your system

    A rectal swab test will be performed to determine the presence of specific bacteria

  3. Step 3

    Final evaluation

    After the monitoring period, medical staff will evaluate whether the treatment was successful in removing specific bacteria from your system

    The evaluation focuses on checking for the presence of specific types of bacteria that are resistant to common antibiotics

    The results will determine if the treatment was effective in eliminating these bacteria from your system

Who can join the trial?

9 criteria

  • Age between 18 and 105 years
  • Must have at least one of these conditions:
    • A positive rectal swab showing bacteria resistant to certain antibiotics (specifically ESBL-E or CRE bacteria)
    • A history of infection with these resistant bacteria within the past year
    • Must be able to swallow 50 capsules in one day
    • Must not have any swallowing difficulties
    • For potential donors:
      • Must be between 18 and 50 years old
      • Must have a body mass index below 30 (a measure of body weight in relation to height)
      • Must have regular bowel movements (at least one bowel movement every 2 days, but no more than 3 per day)
      • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Current active infection requiring antibiotic treatment
  • History of severe allergic reactions
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Inability to swallow capsules
  • Recent (within 3 months) antibiotic treatment
  • Severe immunodeficiency (weakened immune system)
  • Active gastrointestinal disease or disorders
  • Recent (within 3 months) hospitalization
  • History of Clostridium difficile infection (a type of bacterial infection affecting the gut) in the past 6 months
  • Use of medications that suppress the immune system
  • Serious chronic medical conditions that are not well controlled
  • Mental conditions that could affect the ability to follow study procedures
  • History of drug or alcohol abuse within the past year
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Investigated drugs

Fecal Microbiota Transplant (FMT) is a medical treatment that uses stool from a healthy donor, which is processed and delivered in frozen capsule form. The treatment aims to restore healthy gut bacteria. It works by introducing beneficial bacteria from a healthy person's digestive system to help fight against harmful bacteria that are resistant to multiple antibiotics. This treatment is being studied as a way to remove dangerous antibiotic-resistant bacteria from the intestines of affected patients. The treatment involves taking specially prepared capsules that contain carefully screened and processed stool material. The capsules are designed to release their contents in the right part of the digestive system, where the beneficial bacteria can establish themselves and help restore a healthy balance of gut microorganisms.

What is already known about the treatment

Since no specific medication is mentioned in the provided trial data, I can describe the main intervention used in this trial: Fecal Microbiota Transplant (FMT) - A medical treatment delivered in frozen capsule form that contains processed stool from healthy donors, used to restore healthy gut bacteria in patients. This therapy is currently recognized in medical literature as an emerging treatment for various gastrointestinal conditions and bacterial colonization issues. FMT works by introducing beneficial bacteria that can help eliminate harmful multi-drug resistant gram-negative bacteria (MDR-GNB) from the patient's digestive system. It belongs to the category of microbiome-based therapies and represents a novel approach to addressing antibiotic-resistant bacterial colonization through natural biological competition rather than traditional pharmaceutical intervention.

Investigated diseases

  • Multidrug-Resistant Gram-Negative Bacterial Colonization

    A condition where harmful bacteria resistant to multiple antibiotics settle and grow in the human body, particularly in the digestive system. These bacteria have developed the ability to survive treatment with various common antibiotics through genetic changes. The bacteria can live in the body without causing immediate illness but may lead to infections if the person's immune system weakens. The colonization often occurs in healthcare settings and can persist for extended periods. These bacteria include specific groups like CRE (Carbapenem-resistant Enterobacteriaceae) and ESBL-producing organisms (Extended Spectrum Beta-Lactamase).

  • Carbapenem-resistant Enterobacteriaceae (CRE) Colonization

    A specific type of bacterial colonization where Enterobacteriaceae family bacteria have become resistant to carbapenem antibiotics. These bacteria naturally live in the intestines but have developed strong resistance mechanisms. The bacteria can remain in the digestive system without causing symptoms. The colonization can persist for months or even years.

  • Extended Spectrum Beta-Lactamase (ESBL) Colonization

    A condition where bacteria produce enzymes that can break down and resist many common antibiotics. These bacteria typically live in the digestive tract without causing immediate symptoms. The colonization occurs when ESBL-producing bacteria establish themselves in the gut. The bacteria can remain present for extended periods.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516393-29-00Protocol codeAPHP180587Estimated enrolment299 patientsSponsorAssistance Publique Hopitaux De Paris

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