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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
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Crohn's Disease Perianal Fistulas Other: Hyperbaric oxygen Not Applicable

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
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyperbaric oxygen
hyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of fistulas number [ Time Frame: 0, 32 weeks ]
    As assessed by MRI and TRUS


Secondary Outcome Measures :
  1. Reduction of perianal symptoms [ Time Frame: 0, 4, 8, 14, 20, 32 ]
    As assessed by PDAI score


Eligibility Criteria
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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
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Amit Maliar, MD, PhD +972-8-9779066 amitmaliar@yahoo.com

Locations
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Israel
The institute of gastroenterology and liver disease, Assaf Harofe Medical Center Recruiting
Zerifin, Israel, 70800
Sub-Investigator: Amit Maliar, MD, PhD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Haim Shirin, MD Assaf Harofe Medical Center
More Information
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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
Keywords provided by Assaf-Harofeh Medical Center:
crohn's disease
perianal fistulas
TNF alpha blockers
hyperbaric oxygen therapy
Additional relevant MeSH terms:
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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