Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03576027
• Collaborator: Military Institute of Medicine, Poland (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 43.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases; Children, Only	Other: Hyperbaric Oxygen Therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
• Actual Study Start Date: May 21, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyperbaric oxygen therapy	Other: Hyperbaric Oxygen Therapy; Hyperbaric Oxygen Therapy

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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.

2. Concentration of proinflammatory cytokines [40 days]

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Warsaw	Warsaw		Poland	02-091

Sponsors and Collaborators

• Medical University of Warsaw
• Military Institute of Medicine, Poland

Investigators

• Principal Investigator: Lukasz Dembinski, MD, Medical University of Warsaw

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lukasz Dembinski, Principal Investigator, Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT03576027
• Other Study ID Numbers: Dembinski2018
• First Posted: Jul 3, 2018
• Last Update Posted: May 20, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

No Results Posted as of May 20, 2020