Children, Only, Inflammatory Bowel Diseases
Conditions
Brief summary
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.
Interventions
OTHERHyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy
Sponsors
Military Institute od Medicine National Research Institute
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of Crohn's disease or ulcerative colitis according to the criteria from Porto - based on the clinical condition as well as imaging and endoscopic examinations with histopathological assessment; * failure to achieve the remission despite the use of standard treatment in accordance with international guidelines; * written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.
Exclusion criteria
* intolerance of enclosed spaces; * contraindications for hyperbaric therapy: otolaryngological (otitis media, sinusitis); cardiac (clinically significant defects or arrhythmias); pneumological (clinically significant defects) * exacerbation of inflammatory bowel disease during the therapy; * contraindications for hyperbaric therapy in a patient's caregiver in a situation, where the patient requires his/hers presence inside the hyperbaric chamber during the session.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the ulcerative colitis activity | 40 days | Change in the disease activity based on the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis. |
| Change of the Crohn's disease activity | 40 days | Change in the disease activity based on the Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with treatment-related adverse events | 40 days | Number of participants with treatment-related adverse events and the the severity of these events. |
| Concentration of proinflammatory cytokines | 40 days | — |
| Maintaining remission of the ulcerative colitis | 1 year | Duration of the clinical remission time (if achieved) assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis. |
| Maintaining remission of the Crohn's disease | 1 year | Duration of the clinical remission time (if achieved) assessed according to the Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease. |
Countries
Poland
Contacts
Primary ContactLukasz Dembinski, MD
Outcome results
None listed