Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

Medical University of Warsaw

Status: Unknown

Conditions: Children, Only; Inflammatory Bowel Diseases

Treatments: Other: Hyperbaric Oxygen Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03576027

Dembinski2018

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hyperbaric oxygen therapy

Experimental group

Treatment:

Other: Hyperbaric Oxygen Therapy