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2023-507450-32-00CompletedPhase 3

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Dec 2024

Next steps

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
40 (actual)
First submitted
19 Jan 2024
Start date
1 Aug 2024
Lead sponsor
Medical University Of Gdansk
EU CT number
2023-507450-32-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 40
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Uniwersyteckie Centrum KliniczneGdanskPolandCompleted
Uniwersyteckie Centrum Medycyny Morskiej i TropikalnejGdyniaPolandCompleted

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