Cure8 trial brief
Perianal fistulizing Crohn’s disease is difficult to treat and many patients don’t respond to available medical and surgical options. This trial tests an existing wound‑healing therapy (HBOT) in a formal controlled setting that could offer a new treatment pathway if later trials show benefit.
Because the study is early‑phase and not yet recruiting, it does not provide evidence that HBOT works for fistulas—only that a trial to test it is planned.
Adults with perianal fistulizing Crohn’s disease, patients who have failed or are intolerant to biologics/immunosuppressants, colorectal surgeons, gastroenterologists, and researchers interested in HBOT or novel perianal fistula therapies.
This is a registered Phase 1/2 interventional pilot trial testing hyperbaric oxygen therapy (HBOT) for adults with perianal fistulizing Crohn’s disease who are refractory or intolerant to conventional care.
The active intervention is HBOT delivering 100% oxygen at 2.0–2.5 ATA; the control/comparator is standard-of-care (stable immunosuppressive and biologic therapy). The Phase 1 primary outcome is recruitment rate (feasibility) with planned enrollment of 54 total participants across phases.
The protocol excludes rectovaginal fistulas, undrained abscesses (which must be drained and may require seton placement before inclusion), recent local fistula surgery, and patients with diverting ostomies or pouch anatomy.
Prior failure or intolerance to conventional therapies including immunomodulators, anti-TNF agents, vedolizumab, or ustekinumab is required. Safety considerations specific to HBOT (e.g., middle ear barotrauma, contraindications such as claustrophobia or implanted devices) are noted.
This record summarizes a planned trial (NOT_YET_RECRUITING) rather than results; it does not report trial outcomes or effectiveness. It provides rationale referencing small observational studies suggesting benefit but emphasizes the lack of controlled data to date.
This is a trial registration record (Phase 1/2, NOT_YET_RECRUITING) describing study design and eligibility rather than a peer‑reviewed report of results. Prior supportive evidence comes from small observational studies and an open‑label cohort; controlled trial data are lacking.
HBOT carries procedure‑specific contraindications and common minor risks (e.g., middle ear barotrauma).
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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