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Study on Intestifix for Treating Immune Activation in Patients with Liver Cirrhosis and Ascites

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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 the effects of a treatment for patients with cirrhosis and ascites. Cirrhosis is a condition where the liver becomes severely scarred, and ascites is the buildup of fluid in the abdomen, often occurring in people with liver disease. The treatment being tested is called INTESTIFIX 001, which is an encapsulated fecal microbiota transfer, meaning it involves transferring beneficial bacteria from healthy stool into the patient's gut. This study will also use a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The purpose of this study is to evaluate the safety of these FMT capsules in treating immune activation in patients with cirrhosis and ascites. Participants will take the treatment or placebo orally in capsule form. The study will last for about three months, during which participants will have regular check-ups to monitor their health and any side effects. The study aims to see if the treatment can help reduce inflammation and improve liver function and quality of life.

Throughout the study, researchers will observe any serious adverse events and other side effects. They will also measure changes in inflammation markers, liver function scores, and quality of life assessments. The goal is to determine if the treatment is safe and potentially beneficial for patients with these liver conditions. Participants will be closely monitored to ensure their safety and well-being during the trial.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as having cirrhosis and ascites, being between 18 and 70 years old, and the ability to swallow capsules.

    A written informed consent form is signed to confirm understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health metrics. This includes measuring systemic inflammation markers like white blood cell count and C-reactive protein, as well as gut inflammation markers such as fecal calprotectin.

    Scores for liver function and quality of life are recorded using the Child-Pugh score, MELD score, and EQ-5D-5L.

  3. Step 3

    Medication administration

    Participants receive either the Intestifix 001 capsule or a placebo. The medication is taken orally in capsule form.

    The dosage and frequency are determined by the study protocol, and participants are monitored for any adverse effects.

  4. Step 4

    Follow-up visits

    Follow-up visits are scheduled at specific intervals: day 7, day 28, and day 90. These visits involve repeating the initial assessments to track changes in inflammation, organ function, and quality of life.

    The occurrence and severity of any adverse events are recorded during these visits.

  5. Step 5

    End of study

    The study concludes on day 90, with a final assessment to evaluate the overall impact of the treatment.

    The primary focus is on the safety of the treatment, specifically monitoring for any serious adverse events.

Who can join the trial?

6 criteria

  • The patient must have **cirrhosis**, which is a condition where the liver is damaged, from any cause. This should be confirmed by standard medical tests, imaging (like an ultrasound or CT scan), or a tissue sample (biopsy).
  • The patient must have **ascites**, which is a buildup of fluid in the belly, and must have had a procedure to remove or test this fluid in the last 30 days.
  • The patient must be between 18 and 70 years old.
  • The patient must be able to swallow the study capsules, which may contain **Fecal Microbiota Transfer** (FMT) or a placebo (a pill with no active medicine).
  • The patient must be mentally and physically able to understand the study and follow the study rules.
  • The patient must have signed a written consent form agreeing to participate in the study.

Who cannot join the trial?

5 criteria

  • Patients who have a different medical condition than cirrhosis and ascites cannot participate. Cirrhosis is a liver disease, and ascites is a condition where fluid builds up in the belly.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial group cannot participate. This refers to specific characteristics or conditions that the study is focusing on.
  • Patients who are not male or female cannot participate. The study includes both men and women.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.
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Investigated drugs

FMT Capsules are being studied for their potential to treat immune activation in patients with cirrhosis and ascites. These capsules contain fecal microbiota, which are beneficial bacteria from the gut. The idea is that by introducing these healthy bacteria into the patient's system, it may help to balance the gut microbiome and reduce immune system activation, which can be a problem in people with liver disease.

What is already known about the treatment

FMT Capsules – FMT capsules, or fecal microbiota transfer capsules, are administered orally. They are currently being studied in clinical trials, specifically in a phase IIa pilot study, to assess their safety for treating immune activation in patients with cirrhosis and ascites. The main therapeutic indication is to modulate the immune system in these patients. At the molecular level, the mechanism of action involves altering the gut microbiome to influence immune responses. FMT capsules are classified under microbiome-based therapies.

Investigated diseases

  • Cirrhosis

    Cirrhosis is a chronic liver disease characterized by the replacement of healthy liver tissue with scar tissue, which impairs the liver's ability to function properly. Over time, this scarring can lead to liver failure. The disease progresses slowly and can be caused by various factors, including long-term alcohol abuse, hepatitis infections, and fatty liver disease. As cirrhosis advances, symptoms such as fatigue, jaundice, and swelling in the legs and abdomen may occur. Complications can include portal hypertension, liver cancer, and variceal bleeding. The progression of cirrhosis can vary depending on the underlying cause and the individual's overall health.

  • Ascites

    Ascites is a condition characterized by the accumulation of fluid in the abdominal cavity, often due to liver disease such as cirrhosis. This fluid buildup can cause abdominal swelling, discomfort, and difficulty breathing. Ascites develops when the liver's ability to produce proteins and process hormones is impaired, leading to fluid leakage from the blood vessels into the abdominal cavity. The condition can progress to cause infection or kidney problems if not managed. It is often associated with other symptoms of liver disease, such as jaundice and fatigue. The severity of ascites can vary, and it may require medical intervention to manage the symptoms.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507790-18-00Protocol code22-377Estimated enrolment24 patientsSponsorUniversitaetsklinikum Aachen AöR

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