The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
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ClinicalTrials.gov Identifier: NCT01828190 |
Recruitment Status : Unknown
Verified April 2013 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
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Condition or disease | Intervention/treatment | Phase |
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Crohn's Disease Perianal Fistulas | Other: Hyperbaric oxygen | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | March 2015 |
Estimated Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
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Experimental: Hyperbaric oxygen
hyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment.
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Other: Hyperbaric oxygen
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. |
- Reduction of fistulas number [ Time Frame: 0, 32 weeks ]As assessed by MRI and TRUS
- Reduction of perianal symptoms [ Time Frame: 0, 4, 8, 14, 20, 32 ]As assessed by PDAI score

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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)
Exclusion Criteria:
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828190
Contact: Amit Maliar, MD, PhD | +972-8-9779066 | amitmaliar@yahoo.com |
Israel | |
The institute of gastroenterology and liver disease, Assaf Harofe Medical Center | Recruiting |
Zerifin, Israel, 70800 | |
Sub-Investigator: Amit Maliar, MD, PhD |
Principal Investigator: | Haim Shirin, MD | Assaf Harofe Medical Center |
Responsible Party: | Assaf-Harofeh Medical Center |
ClinicalTrials.gov Identifier: | NCT01828190 |
Other Study ID Numbers: |
HBOT- fistulas non-naive |
First Posted: | April 10, 2013 Key Record Dates |
Last Update Posted: | April 10, 2013 |
Last Verified: | April 2013 |
crohn's disease perianal fistulas TNF alpha blockers hyperbaric oxygen therapy |
Crohn Disease Rectal Fistula Fistula Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Pathological Conditions, Anatomical Intestinal Fistula Digestive System Fistula Rectal Diseases |