Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Evaluating the efficacy and safety of hyperbaric oxygen therapy as an adjuvant treatment compared to biologic therapy alone in moderate to severe ulcerative colitis in adults

This study is investigating a new treatment approach for adults with moderate to severe ulcerative colitis. It aims to find out if adding something called hyperbaric oxygen therapy to existing biologic medications (like Stelara, Entyvio, or Zessly) is more effective than using biologic medicines by themselves. The main goal is to see if this combined treatment can help more people achieve complete relief from their symptoms, such as diarrhoea and blood in their poo, and also improve the healing of their gut lining, over 12 months. Researchers will also check how well people respond after 14 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Medical University Of Gdansk

Enrolment target

Start

07 May 2024

Ulcerative colitis

What is this study about?

This study is a research project designed to explore a new way of treating ulcerative colitis, an ongoing condition that causes inflammation and sores in the large bowel. Specifically, it's looking at adults who have moderate to severe ulcerative colitis, meaning their symptoms are quite noticeable and affect their daily lives.

The study is trying to answer an important question: if we combine a special oxygen treatment called hyperbaric oxygen therapy with the biologic medicines many people already use (such as Stelara, Entyvio, or Zessly), will it work better than just using the biologic medicines alone? Hyperbaric oxygen therapy involves breathing pure oxygen in a special high-pressure room. The hope is that this extra oxygen could help reduce inflammation and promote healing in the bowel wall.

The main thing the researchers want to find out is how many people achieve 'clinical remission' after 12 months. This means their symptoms of ulcerative colitis, like diarrhoea and blood in their poo, have completely gone away. They will also check if the inflammation in the bowel has healed when looked at with a camera (an endoscopy). They will also look at how people respond to treatment after a shorter period, specifically 14 weeks.

Key takeaways

New study for adults with moderate to severe ulcerative colitis.
Tests if oxygen therapy improves biologic treatment effectiveness.
Aims to achieve symptom remission (no more diarrhoea or blood in poo).
Participation involves regular visits and medical assessments.
It's a 'Phase III' study, meaning it's a key stage for testing new treatments.

Who may be eligible?

To join this study, participants must be adults, though there isn't an upper age limit specified. Both men and women are welcome to take part in this research.

More detailed criteria about your specific health condition, medical history, and any other medications you are currently taking will determine if you can join. These details are important to make sure the study is safe and that results are clear and accurate.

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 an adult (18 years or older)?
Have you been diagnosed with moderate to severe ulcerative colitis?
Are you able to attend regular clinic visits for a year?
Are you willing to potentially receive either biologic medicine alone or biologic medicine plus oxygen therapy?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be taking part for a total of 12 months, plus any follow-up visits. You would receive either one of the biologic medicines (Stelara, Entyvio, or Zessly) alone, or a combination of one of these biologics plus hyperbaric oxygen therapy. The specific biologic medicine and whether you receive the oxygen therapy would be decided by chance, like flipping a coin. You would have regular visits to the clinic for assessments, which would likely include discussions about your symptoms, physical examinations, and possibly blood tests or stool samples. You would also have an endoscopy (a camera test) at the start and after 12 months to check the healing in your bowel. If you are in the group receiving hyperbaric oxygen therapy, you would attend sessions for this treatment.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as receiving close medical attention and potentially benefiting from a new treatment approach for your ulcerative colitis. However, there are also potential risks, including side effects from the medications or the oxygen therapy, or that the treatment may not work for you. You will be fully informed about all known risks before deciding to participate. Remember, taking part in any clinical trial is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (1)

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

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Unverified
Poland

Common questions

What is hyperbaric oxygen therapy?

It's a treatment where you breathe pure oxygen in a special room with higher air pressure than normal. This increased pressure helps more oxygen get into your blood and tissues.

What are 'biologic therapies'?

Biologic therapies are a type of medicine, often given by injection or infusion, that target specific parts of your immune system to reduce inflammation, which is helpful in conditions like ulcerative colitis.

Will I know which treatment I'm getting?

Often in studies like this, participants are assigned to a treatment group (either biologic alone or biologic plus oxygen therapy) by chance. Sometimes, neither you nor the doctors know which treatment you are receiving until the end of the study to keep results unbiased.

What does a 'Phase III' study mean?

Phase III means this study has reached an advanced stage. It's designed to confirm if a treatment is safe and effective compared to existing options, and to gather more information about its benefits and risks in a larger group of people.

How long will I be in the study?

The main treatment period for this study is 12 months, but you may have follow-up visits after that.