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Study on Allogeneic Faecal Microbiota for Treating Antibiotic-Related Diarrhea in Critically Ill Patients

Fast replyInvestigationalNo placebo
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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 a condition known as post-antibiotic diarrhea, which can occur in patients who are critically ill. This condition often arises after the use of antibiotics, leading to frequent and watery bowel movements. The treatment being tested in this study is a human fecal transplant, which involves transferring healthy bacteria from the stool of a donor into the gut of the patient. This treatment is delivered in the form of a gastroenteral suspension, meaning it is administered directly into the intestines.

The purpose of the study is to determine how effective this treatment is in reducing the symptoms of post-antibiotic diarrhea in critically ill patients. The study will compare the outcomes of patients receiving the fecal transplant to those who do not, to see if the treatment helps in reducing diarrhea by the seventh day after starting the treatment. The fecal transplant used in this study is also known by the code name MaaT 033.

Participants in the study will be monitored over a period of time to assess their response to the treatment. The study will also look at any potential side effects, such as new infections or other serious health issues, to ensure the safety of the treatment. The goal is to see if patients can recover from diarrhea and remain free of symptoms by the time they leave the hospital or by the 28th day of the study, whichever comes first.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will have already provided signed informed consent. This means you have agreed to participate after understanding the study details.

    You must be over 18 years old and currently staying in an Intensive Care Unit (ICU) or High Dependency Unit (HDU), including a burn unit, with an expected stay of more than 7 days.

    You should be experiencing postantibiotic diarrhoea, which is defined as having three or more stools per day or a specific type of stool with a volume greater than 300 ml per day, persisting for 24 hours even after stopping enteral feeding.

  2. Step 2

    Receiving treatment

    The treatment involves a human faecal transplant, which is a gastroenteral suspension made from healthy donor stool. This is administered through the intestinal route.

    The goal is to introduce healthy bacteria into your gut to treat the diarrhoea caused by antibiotics.

  3. Step 3

    Monitoring progress

    Your progress will be monitored to determine the percentage of patients with treatment failure at day 7 after starting the treatment. Treatment failure is defined as either not receiving the treatment for any reason or still having diarrhoea on day 7.

    Additional assessments will include checking for any adverse events, such as new infections or other serious conditions, and evaluating your health status using a scoring system at days 4 and 7.

  4. Step 4

    Completion of study

    The study aims to determine the percentage of patients who are free from diarrhoea recurrence by the time of hospital discharge or by day 28, whichever comes first.

    Subgroup analysis will be conducted to compare patients with different conditions, such as those with specific bacterial infections or those receiving additional antibiotics.

Who can join the trial?

4 criteria

  • Signed informed consent: You need to agree to participate in the study by signing a form.
  • Age: You must be older than 18 years.
  • Hospital stay: You need to be a patient in the Intensive Care Unit (ICU) or High Dependency Unit (HDU), including the burn unit, and expected to stay for more than 7 days.
  • Diarrhoea after antibiotic treatment: You must have diarrhoea, which means having 3 or more loose stools per day or a very watery stool (Bristol type 7) in a volume greater than 300 ml per day if a stool collection device is used. This condition should persist for 24 hours even if the feeding formula given through a tube has been stopped.

Who cannot join the trial?

2 criteria

  • Patients who are not able to receive the assigned treatment for any reason.
  • Patients who still have diarrhoea on day 7 after being randomly assigned to a treatment group.
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Investigated drugs

Faecal Bacteriotherapy is a treatment that involves using stool from a healthy donor to help restore the natural balance of bacteria in the gut. This therapy is used in the trial to help patients who have diarrhea after taking antibiotics. The idea is that the healthy bacteria from the donor stool can help the patient's gut recover and reduce diarrhea symptoms.

What is already known about the treatment

Faecal Bacteriotherapy – Faecal bacteriotherapy is administered through a process known as fecal microbiota transplantation (FMT), where processed stool from a healthy donor is introduced into the gastrointestinal tract of a patient, typically via a colonoscopy, enema, or oral capsules. This treatment is currently being explored in clinical trials for its effectiveness in treating postantibiotic diarrhea in critically ill patients, a condition where diarrhea persists after antibiotic use. The main therapeutic indication is to restore the natural balance of bacteria in the gut, which can be disrupted by antibiotics. At the molecular level, the mechanism involves the reintroduction of beneficial bacteria to outcompete harmful bacteria, thereby restoring gut health. Faecal bacteriotherapy is classified under microbiome-based therapies, focusing on the use of live microorganisms to treat or prevent disease.

Investigated diseases

Postantibiotic Diarrhea in Critically Ill Patients – This condition occurs when patients experience diarrhea following the use of antibiotics, particularly in those who are critically ill. The antibiotics can disrupt the normal balance of bacteria in the gut, leading to an overgrowth of harmful bacteria. This imbalance can cause frequent, watery bowel movements. In critically ill patients, the condition can be more severe due to their weakened state. The progression of the disease involves persistent diarrhea, which can lead to dehydration and electrolyte imbalances if not managed. The condition may resolve once the antibiotic treatment is completed and the gut flora begins to recover.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519024-25-00Protocol codeFEBATRICEstimated enrolment36 patientsSponsorFakultni Nemocnice Kralovske Vinohrady

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