The Influence of Hyperbaric Oxygen in Patients With Perianal Crohn's Disease Already Treated With TNF Alpha Blockers Treated With TNF Alpha Blockers

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828190
• Other study ID #: HBOT- fistulas non-naive
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2015

Study information

• Verified date: April 2013
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Fistula
• Perianal Fistulas
• Rectal Fistula

Intervention

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.

Locations

Country	Name	City	State
Israel	The institute of gastroenterology and liver disease, Assaf Harofe Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of fistulas number	As assessed by MRI and TRUS	0, 32 weeks
Secondary	Reduction of perianal symptoms	As assessed by PDAI score	0, 4, 8, 14, 20, 32