Back to resultsThe Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
Primary Purpose
Crohn's Disease, Perianal Fistulas
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hyperbaric oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring crohn's disease, perianal fistulas, TNF alpha blockers, hyperbaric oxygen therapy
Eligibility 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
Sites / Locations
- The institute of gastroenterology and liver disease, Assaf Harofe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperbaric oxygen
Arm Description
hyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment.
Outcomes
Primary Outcome Measures
Reduction of fistulas number
As assessed by MRI and TRUS
Secondary Outcome Measures
Reduction of perianal symptoms
As assessed by PDAI score
Full Information
NCT ID
NCT01828190
First Posted
April 8, 2013
Last Updated
March 19, 2023
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01828190
Brief Title
The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
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 Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Perianal Fistulas
Keywords
crohn's disease, perianal fistulas, TNF alpha blockers, hyperbaric oxygen therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric oxygen
Arm Type
Experimental
Arm Description
hyperbaric oxygen therapy will be given for 2 months. TNF alpha blocker therapy will remain the treatment received before recruitment.
Intervention Type
Other
Intervention Name(s)
Hyperbaric oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction of fistulas number
Description
As assessed by MRI and TRUS
Time Frame
0, 32 weeks
Secondary Outcome Measure Information:
Title
Reduction of perianal symptoms
Description
As assessed by PDAI score
Time Frame
0, 4, 8, 14, 20, 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Shirin, MD
Organizational Affiliation
Assaf Harofe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The institute of gastroenterology and liver disease, Assaf Harofe Medical Center
City
Zerifin
ZIP/Postal Code
70800
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers
We'll reach out to this number within 24 hrs