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Study on the Effects of Hyperbaric Oxygen Therapy for Patients 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 effects of a treatment called Hyperbaric Oxygen Therapy in patients with ulcerative colitis. Ulcerative colitis is a condition that causes inflammation and sores in the lining of the large intestine. The treatment involves using a special form of oxygen, known as OXYGENE MEDICINAL AIR LIQUIDE REUNION 200 bar, which is inhaled as a gas. This study aims to understand how this therapy affects various aspects of the disease, such as inflammation and healing processes in the gut.

The purpose of the study is to evaluate how this oxygen therapy works at a molecular level in patients who have moderate to severe ulcerative colitis and have not responded well to other medical treatments. The study will look at different factors, including how the therapy affects blood flow in the gut, the presence of immune cells, and the activity of certain genes related to oxygen levels. It will also examine how well the therapy helps in healing the gut lining and how it interacts with other medications the patients might be taking.

Participants in the study will undergo a series of oxygen therapy sessions over a period of time. The study will monitor changes in their condition through various assessments, including clinical evaluations and imaging tests. The goal is to gather information on how effective the therapy is in reducing symptoms and improving the overall health of patients with ulcerative colitis. The study will also compare the results with those of patients who receive a placebo to better understand the therapy's impact.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a documented diagnosis of ulcerative colitis for at least four months and a certain level of disease activity.
Participants must have previously tried and not responded to or tolerated certain medications, such as oral corticosteroids and specific biologic therapies.
Step 2
Treatment initiation
The treatment involves the use of hyperbaric oxygen therapy (HBOT), which is administered as a medicinal gas through inhalation.
The therapy is conducted using a product named OXYGENE MEDICINAL AIR LIQUIDE REUNION 200 bar, which is a compressed medicinal gas.
Step 3
Treatment sessions
Participants undergo a series of HBOT sessions. The number of sessions can vary, with some groups receiving 20, 30, or more sessions.
The sessions are scheduled over a period, with specific assessments conducted on days 2, 4, 6, and the last day of treatment. Additional assessments occur on days 10, 14, and 20 for those with more sessions.
Step 4
Monitoring and assessment
Throughout the treatment, various health parameters are monitored, including disease activity, blood flow, and immune cell populations.
The primary focus is on understanding the molecular effects of the therapy, such as changes in blood and mucosal cells, cytokine profiles, and drug concentrations.
Step 5
Post-treatment evaluation
After completing the HBOT sessions, participants are evaluated for their response to the treatment.
A key measure of success is a reduction in the complete MAYO score, which assesses disease activity, without needing to increase medication doses or switch treatments.
Step 6
Follow-up
Participants are followed up at week 12 post-treatment to assess the long-term effects of the therapy.
The study aims to conclude by July 2025, with ongoing assessments to ensure comprehensive data collection and analysis.

Who can join the trial?

14 criteria

Must have a documented diagnosis of ulcerative colitis for at least 4 months before joining the study. This diagnosis should be confirmed with tests like endoscopy and pathology.
Must have moderately to severely active ulcerative colitis, shown by a total MAYO score of 5 or more and a MAYO ES of 2 or more. These scores should be determined within 7 days of starting the treatment.
Must have tried and not responded to, or not tolerated, certain treatments, including:
Oral corticosteroids
Azathioprine or 6-mercaptopurine
Anti-TNF therapy, such as infliximab, adalimumab, or golimumab
Vedolizumab
Current treatment with ustekinumab or another similar therapy
Must be currently on a stable dose of ustekinumab or tofacitinib for a specific period (more than 12 weeks for ustekinumab and more than 6 weeks for tofacitinib).
Must be 16 years of age or older.
Must have approval for the compassionate use of hyperbaric oxygen therapy from both the treating doctor and the health insurance company.
Must be able to understand and follow the study requirements, as judged by the study doctor.
Must sign and date a written consent form and any necessary privacy documents before starting any study procedures.
Must be male or a non-pregnant, non-breastfeeding female. Females who can have children must have a negative pregnancy test before starting and use birth control during the study. Females who cannot have children must have proof of this, such as a history of surgery or menopause.

Who cannot join the trial?

10 criteria

Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent major surgery.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have an infection that requires treatment with antibiotics.
Patients who have a known allergy to the study medication.
Patients who have a history of cancer, except for certain types of skin cancer.
Patients who have a condition that affects their immune system, like HIV.
Patients who have a history of heart problems, like a heart attack.

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Responsive
Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

Hyperbaric Oxygen Therapy is a treatment that involves breathing pure oxygen in a pressurized room or chamber. In this clinical trial, it is being used to help patients with moderate-to-severe ulcerative colitis who have not responded to other medical treatments. The therapy aims to improve various aspects of the disease, such as reducing inflammation, improving blood flow and oxygen delivery to the affected areas, and promoting healing of the intestinal lining.

Oxygen

What is already known about the treatment

Hyperbaric Oxygen Therapy – This treatment involves administering oxygen at higher than atmospheric pressure, typically in a specialized chamber. It is currently being studied for its effects on moderate-to-severe ulcerative colitis, particularly in patients who do not respond to standard medical treatments. The therapy is believed to enhance oxygen delivery to tissues, reduce inflammation, and promote healing by affecting various molecular pathways, including those dependent on hypoxia-inducible factors. It is classified under supportive therapies that aim to improve tissue oxygenation and healing processes.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to the formation of ulcers. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. Over time, the inflammation can cause 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 genetically susceptible individuals.