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

Phase 1

• Conditions: lcerative colitis; MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-507450-32-00
• Lead Sponsor: Medical University Of Gdansk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 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 Criteria

1. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified