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Study on the Effects of Fecal Microbiome and Fecal Microbiome Filtrate Capsules for Patients with Active Ulcerative Colitis

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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 treatment of ulcerative colitis, a condition that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The study will explore the use of two treatments: Fecal Microbiome Filtrate (FMF) and Fecal Microbiome (FM). Both treatments involve the use of capsules containing a mixture of healthy bacteria from human stool, known as allogeneic fecal microbiota. These capsules are designed to help restore a healthy balance of bacteria in the gut.

The purpose of the study is to evaluate the effectiveness of these treatments in managing active ulcerative colitis. Participants will be randomly assigned to one of three groups: one receiving FMF, another receiving FM, and the third receiving a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment. This helps ensure that the results are unbiased. The study will last for several months, with regular check-ups to monitor the participants' health and the progress of their condition.

Throughout the study, participants will be assessed for improvements in their symptoms, such as reduced inflammation and better overall health. The main goal is to see if the treatments can lead to remission, which means the symptoms of ulcerative colitis are reduced or disappear. Additional assessments will include the impact on quality of life and the safety of the treatments. This trial aims to provide valuable insights into new potential therapies for managing ulcerative colitis.

The research process

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

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age, prior diagnosis of ulcerative colitis, and previous treatment history.
Written consent is required, and understanding of study procedures is necessary.
Step 2
Randomization
Participants are randomly assigned to one of three groups: receiving Fecal Microbiome Filtrate (FMF), Fecal Microbiome (FM), or a placebo.
This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.
Step 3
Treatment administration
Participants receive treatment in the form of hard capsules for oral use.
The treatment involves the long-term transfer of encapsulated stool microbiome.
Step 4
Monitoring and assessments
Regular monitoring occurs to assess the clinical efficacy of the treatment.
Primary assessment is clinical remission at week 12, defined by a Mayo score of 2 or less.
Secondary assessments include steroid-free remission, endoscopic remission, and quality of life evaluations.
Step 5
Completion of study
The study is estimated to conclude by July 31, 2026.
Final assessments are conducted to evaluate the long-term effects and safety of the treatment.

Who can join the trial?

11 criteria

Age between 18 and 75 years
Provide written consent to participate
Have a prior endoscopic confirmation of ulcerative colitis (a type of bowel disease) with the first diagnosis made at least 6 months ago, and currently active disease with a Mayo score (a measure of disease activity) between 4-10 points at screening, and a documented minimum disease extent of 15 cm from the anal verge (with a Mayo endoscopic subscore greater than 1)
Have experienced failure of conventional therapy or treatment with biologicals and/or small molecules
Have previous medical therapy with one of the following:
- Oral 5-ASA compounds (a type of medication) with a stable dose for 4 weeks before randomization
- Azathioprine, 6-MP, or MTX (types of medications) with a stable dose for 8 weeks before randomization
- Oral steroid therapy: prednisone (up to 20 mg/day) or budesonide (up to 9 mg/day) with a stable dose for 2 weeks before randomization
- Topical therapy (foams, enemas) with mesalazine or budesonide with a stable dose for 2 weeks before randomization
- Have previous vaccination against SARS-CoV-2 or previous SARS-CoV-2 infection or positive serology (blood test showing past infection)
- Ability to understand study procedures and willingness to meet requirements associated with participation, such as undergoing endoscopy and taking antibiotics
- If a potentially childbearing patient, must have a negative pregnancy test and use a highly effective contraceptive method

Who cannot join the trial?

1 criterion

Patients with **active ulcerative colitis** cannot participate. This is a condition where the colon and rectum become inflamed, causing symptoms like diarrhea and abdominal pain.

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Verified sites

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

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany

Trial locations

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Investigated drugs

Encapsulated Stool Microbiome
is used in this study to treat active ulcerative colitis. This therapy involves taking capsules that contain a mixture of healthy bacteria from the stool of a donor. The goal is to introduce these beneficial bacteria into the patient's gut to help restore a healthy balance of microorganisms, which may reduce inflammation and improve symptoms of ulcerative colitis.
Faecal Microbiota Filtrate
is another therapy being tested in the trial. This involves using a filtered version of faecal microbiota, which contains the beneficial components of the stool microbiome without the solid matter. The aim is to see if this filtered version can also help in managing ulcerative colitis by promoting a healthier gut environment.

What is already known about the treatment

Encapsulated Stool Microbiome – This medication is administered orally in capsule form. It is currently being studied in clinical trials for its potential to treat active ulcerative colitis. The main therapeutic indication is to manage symptoms and improve the condition of patients with this inflammatory bowel disease. The mechanism of action involves altering the gut microbiome to restore a healthy balance of bacteria, which may reduce inflammation in the colon. It is classified under microbiome-based therapies.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in the gut.