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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507450-32-00
Acronym
NBK121/1/2023
Enrollment
40
Registered
2024-05-07
Start date
Unknown
Completion date
2025-07-10
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Brief summary

The percentage of clinical remission after 12 months of treatment, i.e. the percentage of patients who achieved complete resolution of clinical symptoms of exacerbation of ulcerative colitis (diarrhea and blood in the stool), as well as resolution of endoscopic markers of mucosal inflammation.

Detailed description

1. Assessment of the clinical response rate in the group of patients receiving combination therapy compared to the group of patients receiving biological therapy alone after 14 weeks and 12 months after administration of the first dose of biological drug. 2. Assessment of the percentage of complete clinical remission in the group of patients receiving combined treatment compared to the group of patients receiving biological treatment alone 14 weeks after administration of the first dose of the b

Interventions

Sponsors

Medical University Of Gdansk
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The percentage of clinical remission after 12 months of treatment, i.e. the percentage of patients who achieved complete resolution of clinical symptoms of exacerbation of ulcerative colitis (diarrhea and blood in the stool), as well as resolution of endoscopic markers of mucosal inflammation.

Secondary

MeasureTime frame
1. Assessment of the clinical response rate in the group of patients receiving combination therapy compared to the group of patients receiving biological therapy alone after 14 weeks and 12 months after administration of the first dose of biological drug. 2. Assessment of the percentage of complete clinical remission in the group of patients receiving combined treatment compared to the group of patients receiving biological treatment alone 14 weeks after administration of the first dose of the b

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026