Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases
Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
1 other identifier
interventional
30
1 country
1
Brief Summary
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2018
CompletedFirst Submitted
Initial submission to the registry
June 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedMay 20, 2020
May 1, 2020
3.6 years
June 10, 2018
May 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Number of participants with treatment-related adverse events
40 days
Concentration of proinflammatory cytokines
40 days
Maintaining remission of the ulcerative colitis
1 year
Maintaining remission of the Crohn's disease
1 year
Study Arms (1)
Hyperbaric oxygen therapy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Warsaw
Warsaw, 02-091, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lukasz Dembinski, MD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2018
First Posted
July 3, 2018
Study Start
May 21, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
May 20, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share