Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

Not Applicable

• Conditions: Children, Only; Inflammatory Bowel Diseases
• Interventions: Other: Hyperbaric Oxygen Therapy

• Registration Number: NCT03576027
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-06-10
• Study First Submitted QC: 2018-06-30
• Study First Posted: 2018-07-03
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy	Hyperbaric Oxygen Therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Concentration of proinflammatory cytokines	40 days
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.
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.

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland