Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03576027
• Other study ID #: Dembinski2018
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2020
• Source: Medical University of Warsaw
• Contact: Lukasz Dembinski, MD
• Phone: +48 22 317 9449
• Email: lukaszdembinski[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children, Only
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Other:
• Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Concentration of proinflammatory cytokines		40 days
Secondary	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
Secondary	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