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
Key facts
- Where
- Gdansk és Gdynia, LengyelországSee the 2 sites
- Phase
- 3. fázis
Where in Lengyelország
- Uniwersyteckie Centrum KliniczneGdansk, LengyelországNo longer taking part
- Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdynia, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Gdansk
- Trial code
- EU 2023-507450-32-00
- Record updated
- 2024. december 2.
- Original description
Comparison of the effectiveness of biological treatment (group I, standard treatment) with combined treatment including biological treatment and hyperbaric oxygen therapy (group II, combined treatment).Read full original descriptionShow less
Comparison of the effectiveness of biological treatment (group I, standard treatment) with combined treatment including biological treatment and hyperbaric oxygen therapy (group II, combined treatment).
Inclusion: Patients with moderate or severe ulcerative colitis (disease severity score on the Mayo scale of at least 6 points, of which at least 2 points for endoscopy). 2. Histopathologically confirmed diagnosis of ulcerative colitis for at least 3 months. 3. In patients with a history of ulcerative colitis for 8 years or more: mandatory colonoscopy with control for dysplasia within the last year. 4. Patient's age: 18-70 years. 5. Lack of response to steroid treatment (steroid resistance or steroid dependence) OR lack of response to treatment with azathioprine or mercaptopurine defined as failure to achieve remission despite 12 weeks of treatment, or intolerance to such treatment, or contraindications to such treatment. 1. Steroid resistance - defined as lack of clinical improvement despite the use of a steroid at a daily dose of up to 0.75 mg/kg (calculated as prednisolone) for 4 weeks. 2. Steroid dependence - defined as the inability to reduce the dose of steroids below 10 mg/day (calculated as prednisolone) within 3 months of starting steroid therapy or the recurrence of symptoms within 3 months of discontinuing steroids. 6. Patients qualified for treatment with infliximab, vedolizumab or ustekinumab in the drug program.
Exclusion: Active viral, fungal or bacterial infection constituting a contraindication to biological or immunosuppressive treatment. 2. Malignancy (except pre-cancerous lesions and skin cancer other than melanoma) within the last 5 years. 3. Pregnancy or breastfeeding. 4. Moderate or severe heart failure. 5. Severe liver or kidney disease. 6. Unstable coronary artery disease. 7. Another coexisting disease which, in the opinion of the treating physician, is a contraindication to participation in the program. 8. Contraindications to hyperbaric oxygen treatment, including + middle ear disease + history of pneumothorax + bronchial asthma + chronic obstructive pulmonary disease + pulmonary emphysema + severe claustrophobia.