Back to resultsHyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases
Primary Purpose
Inflammatory Bowel Diseases, Children, Only
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
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.
Sites / Locations
- Medical University of WarsawRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperbaric oxygen therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events and the the severity of these events.
Concentration of proinflammatory cytokines
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.
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.
Full Information
NCT ID
NCT03576027
First Posted
June 10, 2018
Last Updated
May 19, 2020
Sponsor
Medical University of Warsaw
Collaborators
Military Institute od Medicine National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03576027
Brief Title
Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases
Official Title
Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Military Institute od Medicine National Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Children, Only
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
Hyperbaric Oxygen Therapy
Primary Outcome Measure Information:
Title
Change of the ulcerative colitis activity
Description
Change in the disease activity based on the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis.
Time Frame
40 days
Title
Change of the Crohn's disease activity
Description
Change in the disease activity based on the Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.
Time Frame
40 days
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Description
Number of participants with treatment-related adverse events and the the severity of these events.
Time Frame
40 days
Title
Concentration of proinflammatory cytokines
Time Frame
40 days
Title
Maintaining remission of the ulcerative colitis
Description
Duration of the clinical remission time (if achieved) assessed according to the Paediatric Ulcerative Colitis Activity Index (PUCAI) for patients with ulcerative colitis.
Time Frame
1 year
Title
Maintaining remission of the Crohn's disease
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukasz Dembinski, MD
Phone
+48 22 317 9449
Email
lukaszdembinski@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Dembinski, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Dembinski, MD
Phone
+48 22 317 9449
Email
lukaszdembinski@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases
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