Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases

NCT ID: NCT03576027

Last Updated: 2020-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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Conditions

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Inflammatory Bowel Diseases Children, Only

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen therapy

Group Type EXPERIMENTAL

Hyperbaric Oxygen Therapy

Intervention Type OTHER

Hyperbaric Oxygen Therapy

Interventions

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Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military Institute od Medicine National Research Institute

OTHER

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Lukasz Dembinski

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lukasz Dembinski, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Medical University of Warsaw

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Lukasz Dembinski, MD

Role: CONTACT

+48 22 317 9449

Facility Contacts

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Lukasz Dembinski, MD

Role: primary

+48 22 317 9449

Other Identifiers

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Dembinski2018

Identifier Type: -

Identifier Source: org_study_id

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