Hyperbaric Oxygen Therapy for Perianal Fistulizing Crohn's Disease Not Responsive or Intolerant to Conventional Care: HYPNOTIC Pilot Study

NCT06109961 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CRRF ID 5207
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to test a new treatment called hyperbaric oxygen therapy (HBOT) for a severe type of inflammatory bowel disease called perianal Crohn's disease (PCD). PCD causes painful perianal infections and chronic drainage from fistula tracts, and current treatments are only moderately effective and may not be suitable for all patients. HBOT is a safe and commonly used treatment for chronic non-healing wounds and other conditions. Previous studies have suggested that HBOT may help heal fistulas in PCD patients, but these studies were small and lacked controls.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

Perianal Crohn's disease (PCD); Hyperbaric oxygen therapy (HBOT); Tumor necrosis factor (TNF)

Outcome Measures

Primary Outcomes (1)

• Phase 1 recruitment rate

  Primary outcome for phase 1 is the rate of recruitment. Recruitment is defined as the number of randomized patients that receive at least one treatment (active HBOT or control) per year. After one year, recruitment of 20 patients or more (an average of 4 patients per site) will be considered acceptable to proceed to phase 2 without a requirement for modifications, recruitment of 10-20 patients will suggest minor modifications to the protocol are required and recruitment of less than 10 patients will suggest major modifications to the protocol are required prior to proceeding to phase 2.

  1 year

Secondary Outcomes (1)

• Phase 2 numbers of closure all external openings of fistula tracts

  1 year

Study Arms (2)

Active Hyperbaric Oxygen Therapy

EXPERIMENTAL

The active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM).

Drug: Oxygen Gas for Inhalation

Standard of care treatment

OTHER

The standard of care for perianal Crohn's disease (PCD) involves conventional therapies such as immunosuppressive agents and biologics, which can be used to induce and maintain fistula remission. Tumor necrosis factor (TNF) antagonists are considered the first-line therapy for PCD, and clinical trial evidence supports their efficacy in achieving short-term fistula remission.

Other: Standard of care

Interventions

Oxygen Gas for Inhalation DRUG

The active Hyperbaric Oxygen Therapy (HBOT) arm will receive 100% oxygen at 2.0-2.5 atmospheres (ATM).

Active Hyperbaric Oxygen Therapy

Standard of care OTHER

The accepted standard of care for perianal Crohn's disease (PCD) involves conventional therapies such as immunosuppressive agents and biologics, which can be used to induce and maintain fistula remission.

Also known as: Conventional therapies

Standard of care treatment

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (\>17 years old)
• Diagnosis of Crohn's disease based on standard endoscopic, radiologic and/or histologic criteria.
• One or more perianal fistula tract connecting the rectum and the perianal skin. Patients must have active fistula drainage and/or a recurrent perianal abscess within the past month.
• Failure or intolerance of conventional therapy (imuran, methotrexate, anti-TNF therapies, vedolizumab and/or ustekinumab). Failure is defined as persistent perianal drainage or recurrent abscesses after a minimum of 3 months of therapy.
• Standard or care treatment has been stable (dose and treatment interval) for at least 3 months.
• Able to provide written consent to participate

You may not qualify if:

• Fistulas not believed to be due to Crohn's disease (examples include, obstetrical complications, tuberculosis, anorectal cancer or diverticular fistula).
• Rectovaginal fistulas.
• Surgical procedure such as an advancement flap, fistula plug, fistula glue or ligation of intersphincteric fistula tract (LIFT) procedure within the past 6 months.
• Diverting ostomies or ileal pouch anal anastomosis.
• Current or planned pregnancy or lactation during the study treatment period.
• Contraindications to HBOT (claustrophobia, incompatible implanted medical device, and other conditions) based on the discretion of our HBOT clinicians.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Oxygen; Standard of Care

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jeffrey McCurdy, MD

CONTACT

613-737-8899; jmccurdy@toh.ca

Jennifer Kong, MPH

CONTACT

jkong@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, randomized open-label clinical trial and parallel registry.

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 7, 2023

Record last verified: 2023-11