Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

Study Overview
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Brief Summary
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The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.

Official Title
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Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children

Conditions
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Inflammatory Bowel Diseases, Children, Only

Intervention / Treatment
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* Other: Hyperbaric Oxygen Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy<br> | Other: Hyperbaric Oxygen Therapy<br>* Hyperbaric Oxygen Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the ulcerative colitis activity | Change in the disease activity based on the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis. | 40 days | 
| Change of the Crohn's disease activity | Change in the disease activity based on the Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease. | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Number of participants with treatment-related adverse events and the the severity of these events. | 40 days | 
| Concentration of proinflammatory cytokines |  | 40 days | 
| Maintaining remission of the ulcerative colitis | Duration of the clinical remission time (if achieved) assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis. | 1 year | 
| Maintaining remission of the Crohn's disease | 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. | 1 year |