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

March 19, 2023 updated by: Assaf-Harofeh Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Zerifin, Israel, 70800
        • The institute of gastroenterology and liver disease, Assaf Harofe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of fistulas number
Time Frame: 0, 32 weeks
As assessed by MRI and TRUS
0, 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of perianal symptoms
Time Frame: 0, 4, 8, 14, 20, 32
As assessed by PDAI score
0, 4, 8, 14, 20, 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Investigators

  • Principal Investigator: Haim Shirin, MD, Assaf Harofe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBOT- fistulas non-naive

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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