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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01828190

Enrollment

Registered

2013-04-10

Start date

2013-03-31

Completion date

2015-07-31

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Perianal Fistulas

Keywords

crohn's disease, perianal fistulas, TNF alpha blockers, hyperbaric oxygen therapy

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.

Interventions

OTHERHyperbaric 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026