Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Prospective, Open-label Pilot Study to Evaluate Effector Mechanisms of Hyperbaric Oxygen Therapy in Patients with Moderate-to-Severe Ulcerative Colitis: The PARADOX study

The PARADOX study is looking into how a treatment called hyperbaric oxygen therapy (HBOT) affects people with moderate-to-severe ulcerative colitis, a type of inflammatory bowel disease. HBOT involves breathing pure oxygen in a special high-pressure chamber. This study is trying to understand the exact ways HBOT might help reduce inflammation. Researchers will be examining detailed changes in blood cells, the lining of the gut, and the types of bacteria in the gut. They will also measure substances produced by the body called cytokines, look at how well drugs are absorbed, and check blood flow. The goal is to see if HBOT can reduce symptoms and improve the condition, offering a new way to help manage this long-term illness.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Amsterdam UMC

Enrolment target

Start

15 Nov 2024

ulcerative colitis

What is this study about?

This study, called 'PARADOX', is investigating a treatment called hyperbaric oxygen therapy, often shortened to HBOT. It's for people who have moderate-to-severe ulcerative colitis. Ulcerative colitis is a long-term condition where the large intestine (colon) becomes inflamed and develops ulcers, which can cause symptoms like tummy pain, diarrhoea, and tiredness. HBOT involves breathing pure oxygen in a special room or chamber where the air pressure is higher than normal. This extra oxygen can help reduce inflammation and promote healing in the body.

In this study, researchers want to understand exactly *how* HBOT works to help people with ulcerative colitis. They're looking very closely at several things. This includes examining particular cells in the blood and the lining of the gut, studying the different types of bacteria living in the gut, and measuring various chemicals in the body that are linked to inflammation. They will also look at how well medications are working and check blood flow. By understanding these detailed changes, scientists hope to learn if HBOT could be an effective way to help manage ulcerative colitis and improve symptoms.

This is a 'Phase IV' study, which means the treatment (HBOT) is already approved for some uses, but researchers are still gathering more information about its effects, benefits, and how it works for specific conditions like ulcerative colitis. This research could potentially open up a new treatment option for people living with this challenging condition.

Key takeaways

The study explores hyperbaric oxygen therapy (HBOT) for moderate-to-severe ulcerative colitis.
It aims to understand how HBOT works at a very detailed level in the body.
Tests include blood, gut lining, and gut bacteria analysis, plus symptom tracking.
Participation involves HBOT sessions over several weeks and follow-up for 12 weeks.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

The specific details of your ulcerative colitis, such as how severe it is and what treatments you are currently receiving, will be thoroughly reviewed by the study doctors to ensure the study is right for you. They will need to confirm that your condition is considered moderate-to-severe and that you meet all other medical requirements for safe participation.

Every potential participant will have a detailed health check and discussion with the study team to make sure it's safe and appropriate for them to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with moderate-to-severe ulcerative colitis?
Are you able to travel to the study site for treatments and assessments?
Are you comfortable with blood tests and potentially small gut biopsies?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive hyperbaric oxygen therapy (HBOT). This involves going into a special chamber to breathe pure oxygen. The number of HBOT sessions you receive will depend on which group you are in, but it could be up to 30 sessions over several weeks. During the treatment period, you will have regular check-ups to assess your symptoms and overall health. This includes filling out questionnaires about your symptoms on specific days (such as day 2, 4, 6, and the last day of treatment).

The study will also involve taking samples, such as blood samples and possibly small tissue samples from the lining of your gut, to understand how the treatment is affecting your body at a very detailed level. These samples help researchers look at cells, gut bacteria, and chemicals related to inflammation. After your treatment sessions are complete, you will have follow-up assessments for up to 12 weeks to see how you are doing and track any long-term effects of the HBOT. The total duration of your active participation, including follow-up, will be several months.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to reduce your ulcerative colitis symptoms and inflammation through hyperbaric oxygen therapy. However, like all medical treatments, HBOT can have risks, which the study team will explain fully. These might include temporary ear pressure, sinus discomfort, or changes in vision, though severe side effects are rare. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Netherlands

Common questions

What is hyperbaric oxygen therapy (HBOT)?

HBOT is a treatment where you breathe pure oxygen inside a special chamber where the air pressure is higher than normal. This helps more oxygen reach your body's tissues.

Why are researchers looking into HBOT for ulcerative colitis?

Scientists believe the increased oxygen from HBOT might help reduce inflammation and promote healing in the gut, potentially improving symptoms of ulcerative colitis.

What kind of tests will I have in the study?

You might have blood tests, analyses of gut bacteria, and possibly small tissue samples taken from your gut. You will also fill out questionnaires about your symptoms.

Is this a new or experimental treatment?

HBOT is approved for some conditions. For ulcerative colitis, this study is helping researchers understand exactly how it works and if it can be a useful treatment option.

How long will I be in the study?

You would have several sessions of HBOT and then be followed up for about 12 weeks after your treatment finishes. The total time for your active participation would be several months.