Crohn's DiseaseNCT01828190
The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
A study testing Hyperbaric oxygen in people with Crohn's Disease and Perianal Fistulas, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patient suffering from residual Crohn's disease related perianal fistulas already treated with TNF alpha blockers Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease, Perianal Fistulas
- What is being tested?
- Hyperbaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Jul 2015
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18 and above that suffer from Crohn's disease one or more perianal draining fistulas for at least 3 months currently receiving a TNFalpha blocker for at least 3 months (without improvement of the perianal disease)
Who cannot join
- Pregnancy or plans to conceive during the next year Inability (such as previous adverse effects, tuberculosis, concurrent infection etc.)or unwillingness to start or continue with TNF alpha blockers treatment.
- Any past or current malignancy Treatment with HBOT in the last year Claustrophobia Middle ear problems Inability to equalize pressure in the middle ear Medical status that precludes treatment with HBOT such as chest X-ray abnormality, epilepsy, severe congestive heart failure, uncontrolled diabetes or uncontrolled hypertension Any perianal surgery in the last 6 months Any change in Crohn's disease medications in the last 3 months
Trial locations and contacts
1 site in 1 country.
Israel1 site
The institute of gastroenterology and liver disease, Assaf Harofe Medical Center
Tsrifin, 70800
About this study
Official title: Prospective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha Blockers
The aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patient suffering from residual Crohn's disease related perianal fistulas already treated with TNF alpha blockers
Read the detailed description
This study is a prospective open-label study that consists three periods: screening, treatment and follow-up. After signing an informed consent, subjects will be assessed by a gastroenterologist, a surgeon (for the diagnosing the perianal disease and assessing the need for surgery) and a HBOT specialist for assessing the capability of the subject to undergo HBOT treatment.After the screening period, eligible subjects will enter an 8 weeks HBOT treatment period, combined with TNFalpha blocker treatment. This period will be followed by a 4 months follow-up period in which treatment with TNFalpha blocker will continue.
All patients will have an MRI and TRUS examinations to assess the fistulas and also blood tests for CBC, chemistry, inflammatory markers and cytokine analysis. Same evaluation will be repeated at the end of the study.
- Conditions
- Crohn's Disease, Perianal Fistulas
- Being tested
- Hyperbaric oxygen
- Keywords
- crohn's disease, perianal fistulas, TNF alpha blockers, hyperbaric oxygen therapy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygenOther
HBOT will be given for 40 sessions of 2 atmospheres for 90 minutes each session, 5 times a week (2 months). TNF alpha blocker therapy will remain the treatment received before recruitment.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen | Experimental | hyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment. Receives: Other: Hyperbaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of fistulas number
As assessed by MRI and TRUS
Measured: 0, 32 weeks
Secondary outcomes (1)
Reduction of perianal symptoms
As assessed by PDAI score
Measured: 0, 4, 8, 14, 20, 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Haim Shirin, MD, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828190
- Sponsor's protocol ID
- HBOT- fistulas non-naive
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Open-label Study of the Efficacy of the Addition of Hyperbaric Oxygen to the Treatment of Patients With Perianal Fistulas Already Treated With TNF Alpha Blockers
- ClinicalTrials.gov ID
- NCT01828190
- Acronym / sponsor ID
- HBOT- fistulas non-naive
- Conditions
- Crohn's Disease, Perianal Fistulas
- Keywords
- crohn's disease, perianal fistulas, TNF alpha blockers, hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Apr 2013 (estimated)
- 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 aim of this study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patient suffering from residual Crohn's disease related perianal fistulas already treated with TNF alpha blockers
Detailed description
This study is a prospective open-label study that consists three periods: screening, treatment and follow-up. After signing an informed consent, subjects will be assessed by a gastroenterologist, a surgeon (for the diagnosing the perianal disease and assessing the need for surgery) and a HBOT specialist for assessing the capability of the subject to undergo HBOT treatment.After the screening period, eligible subjects will enter an 8 weeks HBOT treatment period, combined with TNFalpha blocker treatment. This period will be followed by a 4 months follow-up period in which treatment with TNFalpha blocker will continue.
All patients will have an MRI and TRUS examinations to assess the fistulas and also blood tests for CBC, chemistry, inflammatory markers and cytokine analysis. Same evaluation will be repeated at the end of the study.
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 | Experimental | Other: Hyperbaric oxygenhyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged 18 and above that suffer from Crohn's disease one or more perianal draining fistulas for at least 3 months currently receiving a TNFalpha blocker for at least 3 months (without improvement of the perianal disease)
Key exclusion criteria (2 listed)
- Pregnancy or plans to conceive during the next year Inability (such as previous adverse effects, tuberculosis, concurrent infection etc.)or unwillingness to start or continue with TNF alpha blockers treatment.
- Any past or current malignancy Treatment with HBOT in the last year Claustrophobia Middle ear problems Inability to equalize pressure in the middle ear Medical status that precludes treatment with HBOT such as chest X-ray abnormality, epilepsy, severe congestive heart failure, uncontrolled diabetes or uncontrolled hypertension Any perianal surgery in the last 6 months Any change in Crohn's disease medications in the last 3 months
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 oxygenHBOT will be given for 40 sessions of 2 atmospheres for 90 minutes each session, 5 times a week (2 months). TNF alpha blocker therapy will remain the treatment received before recruitment. | Other | Hyperbaric oxygen |
Primary outcome
Reduction of fistulas number
Time frame: 0, 32 weeks
As assessed by MRI and TRUS
1 secondary outcome
Reduction of perianal symptoms
Time frame: 0, 4, 8, 14, 20, 32
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
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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.
Haim Shirin, MD principal investigator
Assaf Harofe Medical Center
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 in people with Crohn's Disease and Perianal Fistulas, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Mar 2023. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of fistulas number (time frame: 0, 32 weeks). 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 22 Mar 2023.