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Study on Fecal Microbiota Capsules vs. Placebo for Treating Non-Alcoholic Steatohepatitis in Patients

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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 liver condition called non-alcoholic steatohepatitis (NASH). NASH is a type of liver disease that occurs when fat builds up in the liver, causing inflammation and damage. The study will test a new treatment using lyophilized capsules of fecal microbiota, which are capsules containing specially prepared bacteria from healthy human stool. These capsules are taken by mouth. The treatment is being compared to a placebo to see if it can help improve liver health in people with NASH.

The purpose of the study is to assess how effective, safe, and tolerable the fecal microbiota capsules are for patients with NASH over a period of 72 weeks. Participants will be randomly assigned to receive either the fecal microbiota capsules or a placebo. Throughout the study, participants will have regular check-ups to monitor their liver health and overall well-being. The study aims to see if the treatment can help resolve NASH without worsening liver fibrosis, which is the thickening and scarring of liver tissue.

Participants will also be monitored for any side effects or changes in their health during the study. The study will look at various health indicators, such as liver inflammation, fibrosis, and other health markers, to determine the treatment's impact. The trial is expected to provide valuable information on whether this new treatment can be a safe and effective option for people with NASH.

The research process

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

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age, body mass index, and a previous liver biopsy confirming non-alcoholic steatohepatitis (NASH).
You will be asked to provide informed consent, agreeing to participate in the study and follow the required contraceptive measures if applicable.
Step 2
Randomization
After confirming eligibility, you will be randomly assigned to one of two groups. One group will receive lyophilized capsules of fecal microbiota, and the other will receive a placebo. This process is double-blind, meaning neither you nor the study staff will know which group you are in.
Step 3
Treatment phase
During the treatment phase, you will take the assigned capsules orally. The treatment will last for 72 weeks. The exact dosage and frequency will be provided by the study team.
You will be monitored for any changes in your condition, including liver improvement, and for any side effects or adverse events.
Step 4
Regular assessments
Throughout the study, you will attend regular assessments. These assessments will include various tests and questionnaires to monitor your liver condition, overall health, and any changes in symptoms.
The assessments will also track changes in inflammation, insulin resistance, and other health markers.
Step 5
End of treatment
At the end of the 72-week treatment period, you will have a final assessment to evaluate the outcomes of the treatment.
The study team will review any changes in your liver condition and overall health, as well as any side effects experienced during the trial.
Step 6
Follow-up period
After completing the treatment phase, you will enter a follow-up period. During this time, you may be asked to attend additional visits to monitor your health and any long-term effects of the treatment.
The follow-up period is important to ensure your safety and to gather comprehensive data on the treatment's effectiveness.

Who can join the trial?

8 criteria

Patients must be of any gender and between 18 and 75 years old.
Patients must have a body mass index (BMI) of less than 40 kg/m². BMI is a measure of body fat based on height and weight.
Patients must have a confirmed diagnosis of non-alcoholic steatohepatitis (NASH) through a liver biopsy done within 24 weeks before joining the study. A biopsy is a procedure where a small piece of liver tissue is taken to look for disease.
Patients must have a NASH histological activity score (NAS) of 4 or more. This score measures liver damage and must include a score of 1 or more in each of the following: fat buildup in the liver (steatosis), liver inflammation, and liver cell damage.
Patients must show evidence of liver fibrosis, which is scarring of the liver, at stages 1, 2, or 3. This is determined by the NASH CRN fibrosis score and includes:
- Stage 1: Scarring around certain areas of the liver.
- Stage 2: Scarring in more areas of the liver.
- Stage 3: More severe scarring that connects different areas of the liver.
- Women and men who can have children must agree to use birth control methods from the time they join the study until the first follow-up visit for safety reasons.

Who cannot join the trial?

10 criteria

Patients with any other liver disease besides non-alcoholic steatohepatitis (NASH) cannot participate. NASH is a liver condition that involves fat buildup and inflammation.
Patients who have had a liver transplant are not eligible.
Patients with significant alcohol consumption are excluded. This means drinking more than the recommended limits for alcohol.
Patients with uncontrolled diabetes cannot take part. Uncontrolled diabetes means blood sugar levels are not well managed.
Patients with severe heart disease are not allowed to join the study. Severe heart disease refers to serious problems with the heart's function.
Patients with active cancer, which means cancer that is currently being treated or is growing, are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Patients with known allergies to the study medication or its ingredients are excluded.
Patients with any condition that the study doctors believe would make it unsafe for them to participate are not allowed to join.

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Verified sites

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Hospital Universitario Marques De Valdecilla
Santander, Spain
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Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Spain

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Investigated drugs

Faecal Microbiota Transfer (FMT) in Capsule Form is a treatment that involves taking capsules filled with healthy bacteria from the gut of a donor. The idea is to introduce these good bacteria into the patient's digestive system to help improve liver health. This therapy is being tested to see if it can help people with a liver condition called non-alcoholic steatohepatitis (NASH). The study aims to find out if these capsules can make the liver healthier over a period of 72 weeks and to check if the treatment is safe and well-tolerated by patients.

Allogeneic Faecal Microbiota, Pooled

What is already known about the treatment

Faecal Microbiota Transfer (FMT) in Capsule Form – This medication is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness, safety, and tolerability in treating non-alcoholic steatohepatitis (NASH). The main therapeutic indication for this treatment is to improve liver health in patients with NASH. At the molecular level, FMT works by altering the gut microbiome, which can influence liver function and inflammation. It is classified pharmacologically as a microbiome-based therapy.

Investigated diseases

Non-alcoholic steatohepatitis – Non-alcoholic steatohepatitis (NASH) is a liver disease characterized by inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions known as non-alcoholic fatty liver disease (NAFLD). NASH progresses from simple fatty liver, where fat accumulates without causing harm, to inflammation and liver cell damage. Over time, this can lead to fibrosis, where scar tissue forms in the liver. If the condition continues to progress, it may result in cirrhosis, a severe scarring of the liver that can impair its function. The progression of NASH can vary among individuals, with some experiencing a slow progression and others developing more severe liver damage.