Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Fecal Microbiome Transplantation for Patients with Decompensated Cirrhosis Using Allogeneic Fecal Microbiota Capsules

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying decompensated cirrhosis, a severe stage of liver disease where the liver is significantly damaged and unable to function properly. The study will explore the use of a treatment called fecal microbiome transplantation (FMT), which involves using specially prepared capsules containing healthy bacteria from donor stool to help improve the balance of bacteria in the gut. The treatment being tested is in the form of lyophilized capsules of fecal microbiota, also known by the code name MBK-01. These capsules are taken orally, meaning they are swallowed like a pill.

The purpose of the study is to evaluate whether this treatment can help slow down the progression of decompensated cirrhosis. Participants in the study will be randomly assigned to receive either the fecal microbiome capsules or a placebo, which looks like the treatment but does not contain the active ingredients. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for any changes in their condition, including the time it takes for any new complications of cirrhosis to occur. The study will also track other health outcomes, such as survival rates and the frequency of hospital visits due to cirrhosis complications. Participants will have regular check-ups over a period of time to assess their health and the effects of the treatment. The study aims to provide valuable insights into the potential benefits of fecal microbiome transplantation for people with decompensated cirrhosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of cirrhosis, and other health criteria.

    Women of child-bearing potential must undergo a pregnancy test and agree to use effective contraceptive methods during the study.

  2. Step 2

    Randomization and blinding

    Participants are randomly assigned to receive either the fecal microbiome transplantation (FMT) or a placebo. The study is double-blinded, meaning neither the participants nor the researchers know who receives the actual treatment.

  3. Step 3

    Treatment administration

    Participants receive lyophilized capsules of fecal microbiota or placebo orally. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any changes in their condition. This includes regular assessments at baseline, 1 month, 3 months, 6 months, and 12 months.

    The study evaluates the time to the first decompensation event, transplant-free survival, and mortality rates.

  5. Step 5

    Data collection

    Data is collected on various health parameters, including liver function, inflammatory response, and microbiome composition.

    Quality of life and functional assessments are conducted using specific questionnaires at different intervals.

  6. Step 6

    Completion and analysis

    The study is expected to conclude by June 2028. Results will be analyzed to determine the efficacy of the treatment in halting the progression of decompensated cirrhosis.

Who can join the trial?

4 criteria

  • Must be **18 years old** or older.
  • Must have **cirrhosis**, which is a liver condition, confirmed by standard medical tests, ultrasound, or tissue examination. Cirrhosis can be due to any cause except autoimmune hepatitis. If the cirrhosis is due to a type of liver disease called cholestatic liver disease, the patient must show signs of worsening cirrhosis, like **ascites** (fluid buildup in the belly).
  • Must be classified as **Child-Pugh B or C**, which is a scoring system used to assess the severity of liver disease, with a score between 7 and 12 points.
  • Women who can have children must have a **negative pregnancy test** before joining the study and agree to use very effective birth control methods during the study. These methods include an intrauterine device (IUD), having their fallopian tubes blocked, having a partner who has had a vasectomy, or not having sexual intercourse. Hormonal birth control methods are not allowed due to potential risks to liver health.

Who cannot join the trial?

1 criterion

  • Patients with **decompensated cirrhosis** cannot participate. This is a condition where the liver is severely damaged and cannot function properly.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Fecal Microbiome Transplantation (FMT) is a procedure used in this trial to help patients with decompensated cirrhosis. It involves transferring stool from a healthy donor into the intestines of the patient. The goal is to introduce beneficial bacteria into the patient's gut, which may help improve liver function and prevent further liver damage. This therapy is being tested to see if it can stop the progression of liver disease in these patients.

What is already known about the treatment

Fecal Microbiome Transplantation (FMT) – This treatment involves the administration of processed stool from a healthy donor into the gastrointestinal tract of a patient, typically via colonoscopy, enema, or oral capsules. FMT is currently being studied in clinical trials for its potential to treat decompensated cirrhosis, a severe liver condition. The main therapeutic indication is to halt the progression of this liver disease by restoring a healthy balance of gut bacteria. At the molecular level, FMT works by introducing beneficial bacteria that can outcompete harmful bacteria, reduce inflammation, and improve gut barrier function. It is classified under microbiome-based therapies, a growing area of interest in medicine.

Investigated diseases

Decompensated Cirrhosis – This is a severe stage of liver cirrhosis where the liver can no longer perform its essential functions effectively. It often results from long-term liver damage due to conditions like chronic hepatitis or alcohol abuse. As the disease progresses, patients may experience complications such as fluid accumulation in the abdomen (ascites), kidney dysfunction, bacterial infections, and gastrointestinal bleeding. Additionally, it can lead to hepatic encephalopathy, a condition affecting brain function due to toxins in the blood. The progression of decompensated cirrhosis can lead to acute-on-chronic liver failure, where the liver rapidly loses its ability to function. This stage of cirrhosis requires careful management to address the various complications that arise.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509151-13-00Protocol codeLiverGutEstimated enrolment190 patientsSponsorConsorcio Centro De Investigacion Biomedica En Red

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).