Inflammatory Bowel DiseasesNCT03576027
Hyperbaric Oxygen Therapy in Children With Inflammatory Bowel Diseases
A study testing Hyperbaric Oxygen Therapy in people with Inflammatory Bowel Diseases and Children, Only, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Children, Only
- What is being tested?
- Hyperbaric Oxygen Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 21 May 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, 02-091
Lukasz Dembinski, MD, +48 22 317 9449, lukaszdembinski@gmail.com
About this study
Official title: Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.
- Conditions
- Inflammatory Bowel Diseases, Children, Only
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyOther
Hyperbaric Oxygen Therapy
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Not described Receives: Other: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 days
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.
Measured: 40 days
Secondary outcomes (4)
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events and the the severity of these events.
Measured: 40 days
Concentration of proinflammatory cytokines
Measured: 40 days
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start21 May 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Military Institute od Medicine National Research Institute
- Responsible party
- Principal investigator, Lukasz Dembinski, Medical University of Warsaw
- Investigators
- Lukasz Dembinski, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576027
- Sponsor's protocol ID
- Dembinski2018
- Status last verified
- May 2020
- First submitted
- 10 Jun 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Hyperbaric Oxygen Therapy in the Treatment of Inflammatory Bowel Disease in Children
- ClinicalTrials.gov ID
- NCT03576027
- Acronym / sponsor ID
- Dembinski2018
- Conditions
- Inflammatory Bowel Diseases, Children, Only
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Military Institute od Medicine National Research Institute
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study assesses the effectiveness of hyperbaric oxygen therapy in the treatment of inflammatory bowel disease in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Other: Hyperbaric Oxygen Therapy |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHyperbaric Oxygen Therapy | Other | Hyperbaric oxygen therapy |
Primary outcome
Change of the ulcerative colitis activity
Time frame: 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
Time frame: 40 days
Change in the disease activity based on the Pediatric Crohn's Disease Activity Index (PCDAI) for patients with Crohn's disease.
4 secondary outcomes
Number of participants with treatment-related adverse events
Time frame: 40 days
Concentration of proinflammatory cytokines
Time frame: 40 days
Maintaining remission of the ulcerative colitis
Time frame: 1 year
Maintaining remission of the Crohn's disease
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
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Not yet recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukasz Dembinski, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Inflammatory Bowel Diseases and Children, Only, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Dembinski, MD (+48 22 317 9449, lukaszdembinski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the ulcerative colitis activity (time frame: 40 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.