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Study of Fecal Microbiota Transplantation Compared to Sham Treatment for Patients with Primary Sclerosing Cholangitis

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What is this trial about?

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

This study is looking at Primary Sclerosing Cholangitis, a condition where the bile ducts inside and outside the liver become inflamed and scarred, which can lead to liver damage over time. The study involves patients who also have inflammatory bowel disease, which is a condition causing long-term inflammation of the digestive tract. Participants will already be receiving standard treatment with ursodeoxycholic acid, a medication that helps protect the liver. The study will test a treatment called fecal microbiota transplantation, which involves transferring stool material from healthy donors to the patient. This transplant can be given in different ways: through capsules taken by mouth, through an enema, or through a procedure using a colonoscope. Some participants will receive placebo instead of the actual fecal microbiota transplant.

The purpose of the study is to find out if fecal microbiota transplantation can improve certain blood test results that indicate how well the liver is functioning, specifically levels of alkaline phosphatase and bilirubin, which are substances that can build up when the liver or bile ducts are not working properly. The study will compare the results between patients who receive the actual fecal microbiota transplant and those who receive the placebo treatment.

During the study, patients will be monitored for 48 weeks with regular visits where blood tests will be done to check liver function. Additional tests will include measurements of liver stiffness, imaging of the bile ducts using magnetic resonance cholangiography, and colonoscopy to check the bowel condition. Patients will also complete questionnaires about symptoms like itching, fatigue, and quality of life. Stool samples will be collected to study changes in the gut bacteria. Some patients may continue to be followed for up to 104 weeks to assess longer-term effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase begins

    The trial starts after randomization, where you will be assigned to receive either the active treatment or placebo.

    The active treatment consists of fecal microbiota transplantation, which involves transferring processed stool material from healthy donors to your digestive system. The placebo is an inactive substitute that looks similar but contains no active microbiota.

    You will continue taking your standard medication called ursodeoxycholic acid (UDCA) at the same dose you have been taking (13-23 mg per kilogram of body weight per day) throughout the entire trial.

  2. Step 2

    Treatment administration

    You will receive the treatment through two possible routes: either by oral capsules that you swallow, or by rectal administration (enema or colonoscopic procedure).

    If you receive oral treatment, you will take double encapsulated capsules containing either the fecal microbiota or placebo.

    If you receive rectal treatment, the fecal microbiota or placebo will be administered as a suspension (liquid form) either through an enema or during a colonoscopy procedure.

    The specific number of administrations and exact timing are determined by the trial protocol.

  3. Step 3

    Week 12 assessment

    At week 12, you will have blood tests to measure liver function markers including alkaline phosphatase (ALP), bilirubin, and other liver enzymes.

    You will complete questionnaires about itching intensity using a visual scale and a detailed 5-dimension scale.

    A stool sample will be collected to analyze the composition of bacteria in your gut (gut microbiota analysis).

  4. Step 4

    Week 24 assessment

    At week 24, you will have blood tests to measure liver function markers including alkaline phosphatase (ALP), bilirubin, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT).

    You will complete questionnaires about itching intensity, quality of life, symptoms related to chronic liver disease, and fatigue levels.

    Prognostic scores will be calculated based on your test results to assess disease progression.

    A stool sample will be collected for gut microbiota analysis.

    You will provide a stool sample to measure fecal calprotectin, a marker that indicates inflammation in the intestines.

  5. Step 5

    Week 36 assessment

    At week 36, you will have blood tests to measure liver function markers.

    You will complete questionnaires about itching intensity.

    A stool sample will be collected for gut microbiota analysis.

  6. Step 6

    Week 48 primary assessment

    At week 48, you will have comprehensive blood tests to measure all liver function markers including alkaline phosphatase (ALP), bilirubin, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), and alanine aminotransferase (ALT).

    You will complete questionnaires about itching intensity, quality of life, symptoms related to chronic liver disease, and fatigue levels.

    Blood will be drawn to measure bile acids using a specialized laboratory technique called chromatography.

    You will undergo an elastometry examination, which is a non-invasive test that measures liver stiffness to assess fibrosis (scarring of the liver).

    You will have a magnetic resonance cholangiography (MRC), which is an imaging scan that visualizes the bile ducts to assess any changes compared to the beginning of the trial.

    You will undergo a colonoscopy, which is an examination of the large intestine using a flexible tube with a camera. This procedure assesses the activity of inflammatory bowel disease using specific scoring systems.

    A stool sample will be collected for gut microbiota analysis and to measure fecal calprotectin.

    You will complete clinical scoring questionnaires specific to your type of inflammatory bowel disease to assess disease activity.

    Prognostic scores will be calculated based on your test results.

  7. Step 7

    Extended follow-up period

    After week 48, you will continue to be monitored until week 104 (approximately 2 years from the start of the trial).

    During this period, you will be assessed for any adverse events, including infections, changes in inflammatory bowel disease activity, and liver-related complications.

    Specific assessments during this extended period will be determined by the trial protocol.

  8. Step 8

    End of trial at week 104

    The trial concludes at week 104.

    Final safety assessments will be conducted to evaluate any adverse events that occurred throughout the entire trial period.

Who can join the trial?

10 criteria

  • You must be male or female
  • You must be between 18 and 75 years old
  • You must have Primary Sclerosing Cholangitis, which is a disease affecting the bile ducts in the liver, confirmed by special imaging tests that show typical changes in the bile ducts
  • You must have Inflammatory Bowel Disease (a condition causing inflammation in the digestive tract) diagnosed according to standard guidelines with signs seen during examination of the bowel and under the microscope
  • Your Inflammatory Bowel Disease must be inactive for at least 6 months, meaning you have had no flare-ups and no changes in your treatment during this time
  • Your blood test results must show either alkaline phosphatase (a liver enzyme) levels at least 1.3 times higher than normal (measured at least 2 times within 3 months before joining the study), or elevated total bilirubin (a substance produced when red blood cells break down) up to a certain level along with elevated direct bilirubin
  • You must have been taking UDCA (a medication used to treat liver disease) at a dose of 13-23 milligrams per kilogram of body weight per day for at least 6 months, and at the same dose for at least 3 months
  • If you are a woman who can become pregnant, you must use highly effective birth control methods with less than 1% failure rate when used correctly
  • You must be enrolled in the French Social Security System
  • You must provide written informed consent, meaning you agree in writing to participate after being informed about the study

Who cannot join the trial?

3 criteria

  • The study has not provided specific exclusion criteria information in the available data
  • Please note that general exclusion criteria for clinical trials typically exist but are not listed in the source document provided
  • For this particular study involving Primary Sclerosing Cholangitis (a chronic disease affecting the bile ducts in the liver), specific reasons why patients cannot participate have not been detailed in the available information
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Investigated drugs

  • Fecal Microbiota Transplantation (FMT)

    is a treatment where stool from a healthy donor is transferred into the patient's digestive system. The purpose is to introduce beneficial bacteria into the gut, which may help improve the condition being studied. In this trial, FMT is being tested to see if it can help patients with a liver disease by improving certain blood markers that indicate how well the liver is working.

  • Sham Transplantation

    is a fake or pretend treatment that looks like the real fecal microbiota transplantation but does not contain the active beneficial bacteria. It is used as a comparison to help researchers understand if the real treatment is actually working. Patients receiving the sham treatment will go through the same procedure but without receiving the therapeutic stool sample.

  • UDCA (Ursodeoxycholic Acid)

    is a medication commonly used to treat certain liver and bile duct conditions. It is a bile acid that helps protect the liver and improve bile flow. In this trial, all patients will continue taking UDCA as their standard treatment while also receiving either the fecal microbiota transplantation or the sham transplantation.

What is already known about the treatment

Fecal Microbiota Transplantation – Fecal microbiota transplantation (FMT) is a procedure where stool from a healthy donor is transferred into a patient's intestines, typically through colonoscopy, endoscopy, or capsules taken by mouth. In this clinical trial, FMT is being studied as an experimental treatment for Primary Sclerosing Cholangitis, a rare disease that causes scarring and damage to the bile ducts in the liver. The treatment works by introducing healthy gut bacteria to restore the balance of microorganisms in the intestines, which may help reduce liver inflammation and improve bile duct function through the gut-liver connection. FMT is currently an approved treatment for certain severe intestinal infections but remains under investigation for liver diseases, and this study aims to determine if it can improve liver function markers when used alongside standard therapy.

Investigated diseases

Primary Sclerosing Cholangitis – Primary Sclerosing Cholangitis is a chronic liver disease that affects the bile ducts, which are tubes that carry digestive fluid called bile from the liver to the small intestine. In this condition, inflammation causes scarring of the bile ducts, making them narrow and blocked over time. As the bile ducts become damaged, bile builds up in the liver, which gradually damages liver tissue. The disease progresses slowly and can lead to liver scarring known as cirrhosis. Many people with this condition also have inflammatory bowel disease, particularly ulcerative colitis. Symptoms may include itching, fatigue, yellowing of the skin and eyes, and abdominal discomfort, though some people have no symptoms in the early stages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-505469-95-00Protocol codeAPHP211053Estimated enrolment72 patientsSponsorAssistance Publique Hopitaux De Paris

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