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Study on the Effects of Oxygen Therapy with Vedolizumab, Ustekinumab, or Infliximab for Adults with Moderate to Severe Ulcerative Colitis

Verified siteRegistered drugNo placebo

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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. The study aims to evaluate the effectiveness and safety of using hyperbaric oxygen therapy as an additional treatment compared to using biological therapy alone. Biological therapies being studied include Entyvio (vedolizumab), Stelara (ustekinumab), and Zessly (infliximab). These treatments are typically used to help manage symptoms and reduce inflammation in patients with moderate to severe ulcerative colitis.

The purpose of the study is to compare the effectiveness of standard biological treatment with a combined approach that includes both biological treatment and hyperbaric oxygen therapy. Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized room or chamber, which can help improve the healing process. The study will observe patients over a period of time to see if the combined treatment leads to better outcomes than biological therapy alone.

Participants in the study will receive either the standard biological treatment or the combined treatment with hyperbaric oxygen therapy. The study will monitor the percentage of patients who achieve complete resolution of symptoms, such as diarrhea and blood in the stool, and the healing of the intestinal lining. The trial will last for up to 12 months, with assessments at various points to evaluate the effectiveness of the treatments. The goal is to determine if adding hyperbaric oxygen therapy can enhance the benefits of biological treatments for those with moderate to severe ulcerative colitis.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of moderate to severe ulcerative colitis, confirmed by a histopathological examination.
Eligibility criteria include a Mayo scale score of at least 6 points, with at least 2 points for endoscopy, and a history of ulcerative colitis for at least 3 months. Additional criteria apply for those with a history of 8 years or more.
Step 2
Treatment group assignment
Participants are assigned to one of two groups: Group I receives standard biological treatment, while Group II receives a combination of biological treatment and hyperbaric oxygen therapy.
Step 3
Biological treatment administration
Biological treatment involves the administration of one of the following medications: infliximab, vedolizumab, or ustekinumab. These are administered via intravenous infusion.
The specific medication and dosage depend on individual patient needs and are determined by the healthcare provider.
Step 4
Hyperbaric oxygen therapy
Participants in Group II receive hyperbaric oxygen therapy in addition to biological treatment. This involves inhaling oxygen in a pressurized chamber, which is intended to enhance the effectiveness of the treatment.
Step 5
Monitoring and follow-up
Participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes clinical evaluations and endoscopic assessments.
The primary goal is to achieve clinical remission, defined as the complete resolution of symptoms such as diarrhea and blood in the stool, as well as the resolution of endoscopic markers of inflammation.
Step 6
Evaluation of outcomes
The primary outcome is assessed after 12 months of treatment, focusing on the percentage of patients achieving clinical remission.
Secondary outcomes include the assessment of clinical response rates and remission rates at 14 weeks and 12 months after the first dose of the biological drug.

Who can join the trial?

9 criteria

Patients must have **ulcerative colitis**, which is a condition that causes inflammation in the colon.
The condition should be **moderate or severe**, with a disease severity score of at least 6 points on the Mayo scale, including at least 2 points for endoscopy. The Mayo scale is a tool used to measure how severe the disease is.
The diagnosis of ulcerative colitis must be confirmed through a **histopathological** examination, which is a detailed study of tissue samples, and the diagnosis should have been made at least 3 months ago.
If the patient has had ulcerative colitis for 8 years or more, they must have had a **colonoscopy** within the last year to check for **dysplasia**, which means abnormal cells that could lead to cancer.
Patients should be between **18 and 70 years old**.
Patients must not have responded to **steroid treatment** or have issues with other treatments:
- **Steroid resistance** means no improvement after using steroids at a specific dose for 4 weeks.
- **Steroid dependence** means not being able to reduce the steroid dose below a certain level within 3 months or symptoms returning within 3 months after stopping steroids.
- No response to treatment with **azathioprine** or **mercaptopurine**, which are medications used to treat ulcerative colitis, after 12 weeks, or if the patient cannot tolerate these medications or has reasons not to use them.
- Patients should be eligible for treatment with **infliximab**, **vedolizumab**, or **ustekinumab**, which are specific medications used in a drug program for treating ulcerative colitis.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the lining of the large intestine.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means people who might need special protection or care.

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Verified sites

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

Verified
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Verified
Uniwersyteckie Centrum Medycyny Morskiej I Tropikalnej
Gdynia, Poland

Trial locations

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Investigated drugs

Biologic Therapy
is a standard treatment used in this trial for moderate to severe ulcerative colitis in adults. It involves using medications that target specific parts of the immune system to reduce inflammation and manage symptoms of the disease. These medications are designed to help control the immune response that contributes to the inflammation in the colon.
Hyperbaric Oxygen Therapy
is an additional treatment being evaluated in this trial. It involves breathing pure oxygen in a pressurized room or chamber. This therapy is thought to enhance the body's natural healing processes by increasing the amount of oxygen in the blood, which may help reduce inflammation and promote healing in the colon when used alongside biologic therapy.

What is already known about the treatment

Hyperbaric Oxygen Therapy – This treatment involves breathing pure oxygen in a pressurized room or chamber, which is administered to enhance the body's natural healing processes. It is currently being evaluated in clinical trials as an additional treatment for moderate to severe ulcerative colitis, alongside standard biological therapies. The main therapeutic indication is to improve the effectiveness of existing treatments for ulcerative colitis. At the molecular level, it is believed to reduce inflammation and promote tissue repair by increasing oxygen delivery to affected areas. It is classified under supportive therapies that enhance the efficacy of primary treatments.

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 persistent diarrhea, abdominal pain, and the presence of blood in the stool. The disease typically progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as narrowing of the colon or increased risk of colon cancer. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in the gut.