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Study of Fecal Microbiota Capsules 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 compared to a placebo to see if they 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 over a period of 72 weeks. Participants will take the capsules orally, and their liver health will be monitored throughout the study. The study aims to see if the treatment can resolve NASH without worsening liver fibrosis, which is the thickening and scarring of liver tissue. Additionally, the study will look at changes in liver inflammation, fat content in the liver as measured by MRI, and other health markers.

Participants will be observed for any side effects or changes in their health during the study. The trial will also track improvements in liver inflammation and other health indicators, such as insulin resistance and cholesterol levels. The study is designed 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 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study involves the use of lyophilized capsules of fecal microbiota for the treatment of non-alcoholic steatohepatitis (NASH).
Participants will receive these capsules orally. The exact dosage and frequency will be determined by the study protocol and communicated to participants at the start of the trial.
Step 2
Treatment duration
The treatment with the capsules will last for a period of 72 weeks.
During this time, the efficiency, safety, and tolerability of the treatment will be assessed.
Step 3
Monitoring and assessments
Throughout the 72 weeks, participants will undergo regular monitoring to assess liver improvement and any potential side effects.
Assessments will include changes in liver condition, occurrence of adverse events, and changes in vital signs and laboratory results.
Step 4
End of treatment evaluation
At the end of the treatment period, a final evaluation will be conducted to determine the resolution of NASH without worsening of fibrosis.
Additional assessments will include changes in inflammation, fibrosis biomarkers, and other health indicators.

Who can join the trial?

6 criteria

Patients must be between 18 and 75 years old.
Patients should have a body mass index (BMI) of less than 40 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.
Patients need a confirmed diagnosis of non-alcoholic steatohepatitis (NASH) from a liver biopsy done within 24 weeks before agreeing to join the study. NASH is a liver condition that involves inflammation and damage.
Patients must have a NASH histological activity score (NAS) of 4 or higher. This score measures the severity of NASH based on liver tissue examination, including fat buildup, liver cell inflammation, and liver cell damage.
Patients should have evidence of liver fibrosis at stage 1, 2, or 3. Fibrosis is the formation of excess tissue in the liver, and these stages indicate the extent of liver damage.
Women and men who can have children must agree to use birth control methods from the time they agree to join the study until the first follow-up visit, to ensure safety.

Who cannot join the trial?

7 criteria

Patients who have a history of **alcohol abuse** or **alcohol-related liver disease** cannot participate. This means if you have had problems with alcohol that affected your liver, you are not eligible.
Patients with **other liver diseases** besides non-alcoholic steatohepatitis (NASH) are excluded. If you have liver issues not related to NASH, you cannot join the study.
Patients who have had a **liver transplant** are not eligible. This means if you have received a new liver from a donor, you cannot participate.
Patients with **severe heart problems** are excluded. If you have serious heart conditions, you cannot take part in the study.
Patients who are **pregnant or breastfeeding** cannot participate. If you are expecting a baby or nursing, you are not eligible.
Patients who are **unable to swallow capsules** are excluded. If you have difficulty swallowing pills, you cannot join the study.
Patients who have participated in another **clinical trial** within the last 30 days are not eligible. If you have been part of a different study recently, you cannot take part in this one.

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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 This therapy involves taking capsules that contain a preparation of healthy bacteria from the stool of a donor. The goal is to introduce these beneficial bacteria into the gut of patients with non-alcoholic steatohepatitis (NASH) to help improve liver health. The study aims to see if this treatment can effectively improve liver function and is safe and well-tolerated over a period of 72 weeks.

Allogeneic Faecal Microbiota, Pooled

What is already known about the treatment

Faecal Microbiota Transfer (FMT) in Capsule Form – This medication is administered orally in capsule form. It is currently being studied in clinical trials for its effectiveness, safety, and tolerability in treating non-alcoholic steatohepatitis (NASH). The main therapeutic indication is to improve liver health in patients with NASH. The mechanism of action involves altering the gut microbiome to promote a healthier balance of bacteria, which may positively impact liver function. It is classified under microbiome-based therapies.

Investigated diseases

Non-alcoholic steatohepatitis – This is a liver disease characterized by the accumulation of fat in the liver, inflammation, and liver cell damage. It is part of a group of conditions known as non-alcoholic fatty liver disease. The disease progresses from simple fatty liver to inflammation and damage, which can lead to scarring of the liver tissue. Over time, this scarring can become more severe, potentially affecting liver function. The condition is often associated with obesity, insulin resistance, and metabolic syndrome. It is important to monitor the disease to prevent further liver damage.