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Study on Fecal Microbiota Transplantation with Infliximab and Vedolizumab for Patients with 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 effects of a treatment for ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The study involves two medications: infliximab and vedolizumab. Infliximab is also known by other names such as Zessly and Remsima, while vedolizumab is also known as Entyvio. These medications are used to help reduce inflammation in the body. The trial also includes a procedure called fecal microbiota transplantation (FMT), which involves transferring stool from a healthy donor to the patient to help restore healthy bacteria in the gut.

The purpose of this study is to explore the potential benefits of combining FMT with either infliximab or vedolizumab. Participants will receive either FMT combined with infliximab, FMT combined with vedolizumab, or one of the medications alone. The study will last for about 12 weeks, during which participants will receive treatments and have their health monitored regularly. The goal is to see if the combination of FMT with these medications can improve symptoms more effectively than the medications alone.

Throughout the study, researchers will assess various health indicators, such as the level of inflammation in the gut, overall quality of life, and any side effects experienced. The study aims to provide insights into whether this combined treatment approach can lead to better outcomes for patients with active ulcerative colitis. 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.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age between 18-75 years, active ulcerative colitis, and no previous exposure to certain medications.
Informed consent is required to participate in the study.
Step 2
Treatment initiation
The treatment involves the administration of infliximab or vedolizumab in combination with a fecal microbiota transplant (FMT).
Infliximab is administered as an intravenous infusion, starting with a dosage of 100 mg.
Vedolizumab is administered as an intravenous infusion, starting with a dosage of 300 mg.
Step 3
Subsequent treatments
Following the initial infusion, infliximab is administered as a subcutaneous injection with a dosage of 120 mg.
Vedolizumab is administered as a subcutaneous injection with a dosage of 108 mg.
The frequency and duration of these treatments are determined by the study protocol.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the effectiveness and safety of the treatment.
Primary assessments include achieving steroid-free clinical remission by week 14 from the first FMT and week 12 from the first infusion.
Secondary assessments include endoscopic healing, improvement in quality of life, and other health indicators such as weight and blood pressure.
Step 5
Completion of study
The study is estimated to conclude by March 2026.
Final assessments are conducted to evaluate the overall outcomes and any adverse events experienced during the trial.

Who can join the trial?

4 criteria

Age between 18 and 75 years old.
Have active ulcerative colitis or a condition where you rely on corticosteroids and need treatment with special medicines called biological agents.
Have not used certain medicines before, like TNF blockers, vedolizumab, or other similar medicines. This is called being bionaive.
Must sign a document called informed consent, which means you understand the study and agree to take part.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of Ulcerative Colitis or Crohn's disease cannot participate. These are conditions that cause inflammation in the digestive tract.
Patients who are not within the specified age range cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
Patients who do not meet other specific criteria set by the study cannot participate. These criteria are important to ensure the safety and effectiveness of the study.

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Verified sites

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Helsinki University Central Hospital
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Helsinki, Finland

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Investigated drugs

Infliximab
is a medication used to treat ulcerative colitis by reducing inflammation in the colon. It works by blocking a protein in the body that causes inflammation, helping to relieve symptoms and improve the condition.
Vedolizumab
is another medication used for ulcerative colitis. It targets specific areas in the gut to reduce inflammation and help manage symptoms. It is often used when other treatments have not been effective.
Fecal Microbiota Transplantation (FMT)
is a procedure that involves transferring stool from a healthy donor into the gastrointestinal tract of a patient. This is done to restore a healthy balance of bacteria in the gut, which can help improve symptoms in patients with ulcerative colitis.

What is already known about the treatment

Infliximab
Infliximab is administered through intravenous infusion and is currently used in the treatment of autoimmune conditions like ulcerative colitis and Crohn's disease. It is well-documented in medical literature as a biologic therapy that targets and neutralizes tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. Infliximab is classified as a monoclonal antibody and is primarily indicated for reducing inflammation and managing symptoms in patients with these conditions.
Vedolizumab
Vedolizumab is given by intravenous infusion and is used to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. It is recognized in medical literature as a biologic medication that specifically blocks the interaction of integrin alpha-4-beta-7 with mucosal addressin cell adhesion molecule-1 (MAdCAM-1), which helps reduce inflammation in the gut. Vedolizumab is classified as an integrin receptor antagonist and is mainly indicated for patients who have not responded well to conventional therapies.

Investigated diseases

Ulcerative Colitis
This is a chronic inflammatory condition affecting the colon and rectum. It causes inflammation and ulcers in the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remission. Over time, it can lead to complications such as severe bleeding or colon damage. The exact cause is unknown, but it involves an abnormal immune response.
Crohn's Disease
This is a long-term inflammatory bowel disease that can affect any part of the gastrointestinal tract, from the mouth to the anus. It often leads to symptoms like abdominal pain, severe diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue. The disease is characterized by periods of active symptoms and remission. It can cause complications such as bowel obstruction or malnutrition. The exact cause is not fully understood, but it involves an immune system malfunction.