ulcerative colitis
Conditions
Brief summary
Co-primary endpoints include: methylome of peripheral blood and mucosal monocytes, mucosal single transcriptomics, cytokine profiles, microbiome, drug concentrations and blood flow
Detailed description
- Response after completion of HBOT and at week 12 post-treatment defined as a reduction in complete MAYO score of 3 points AND at least 1 point reduction in the MAYO ES WITHOUT escalating therapy such as dose escalations, switching to another drug, adding corticosteroids or colectomy, - Clinical disease activity assessed by the PRO-2 score during treatment at day 2, 4, 6 and the last day of treatment, for the group with 20 and 30 sessions: day 10 and 14 and the group with 30 sessions: day 20,
Interventions
Sponsors
Stichting Amsterdam UMC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints include: methylome of peripheral blood and mucosal monocytes, mucosal single transcriptomics, cytokine profiles, microbiome, drug concentrations and blood flow | — |
Secondary
| Measure | Time frame |
|---|---|
| - Response after completion of HBOT and at week 12 post-treatment defined as a reduction in complete MAYO score of 3 points AND at least 1 point reduction in the MAYO ES WITHOUT escalating therapy such as dose escalations, switching to another drug, adding corticosteroids or colectomy, - Clinical disease activity assessed by the PRO-2 score during treatment at day 2, 4, 6 and the last day of treatment, for the group with 20 and 30 sessions: day 10 and 14 and the group with 30 sessions: day 20, | — |
Countries
Netherlands
Outcome results
None listed