Trial Summary
What is the purpose of this trial?Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.
Is Hyperbaric Oxygen Therapy a promising treatment for Ulcerative Colitis?Yes, Hyperbaric Oxygen Therapy (HBOT) is a promising treatment for Ulcerative Colitis. It has been shown to improve short-term outcomes for patients with severe flares, help in healing the colon, and reduce the need for urgent medical treatments.13456
What safety data is available for hyperbaric oxygen therapy in treating ulcerative colitis?The safety of hyperbaric oxygen therapy (HBOT) for ulcerative colitis has been explored in various studies. A phase 2A pilot trial found HBOT to be well tolerated in patients with moderate-severe flares. A systematic review protocol aims to evaluate the safety and efficacy of HBOT, although conclusive evidence is still pending. Overall, while some studies suggest HBOT is safe, comprehensive safety data is still being gathered.23467
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, you must be able to receive intravenous steroids and cannot start new biologics or small molecules during hospitalization before randomization.
What data supports the idea that Hyperbaric Oxygen Therapy for Ulcerative Colitis is an effective treatment?The available research shows that Hyperbaric Oxygen Therapy (HBOT) can be effective for patients with ulcerative colitis, especially those hospitalized for severe flares. One study found that HBOT helped patients achieve short-term remission and reduced the need for additional urgent treatments. Another study indicated that HBOT improved short-term outcomes for patients with acute flares. However, one study noted that HBOT did not improve outcomes when added to standard treatments for severe attacks. Overall, while some studies show promising results, more research is needed to fully understand its effectiveness.13456
Eligibility Criteria
This trial is for adults aged 18-85 with known or newly diagnosed Ulcerative Colitis (UC) who are hospitalized due to a severe flare-up. They must be able to start hyperbaric oxygen therapy within 48 hours after beginning steroid treatment and cannot have certain colitis types, complications needing urgent surgery, major organ impairments, recent investigational drug use, pregnancy/nursing status, or active COVID-19.Treatment Details
The study tests if Hyperbaric Oxygen Therapy (HBOT), which involves breathing pure oxygen under pressure to increase tissue oxygen levels, can help hospitalized UC patients avoid worsening conditions and the need for more intense treatments. It compares HBOT's effectiveness against a sham air treatment in improving remission rates.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hyperbaric Oxygen TherapyExperimental Treatment1 Intervention
Participants enrolled in the active intervention group receiving HBOT will undergo compression to 2.4 Atmospheres Absolute (ATA; 100% O2) for 90 minutes with two 5-10 minute "air breaks" (breathing room air at the 2.4 ATA) during the session. This is done once a day for 5 days.
Group II: Sham Hyperbaric AirPlacebo Group1 Intervention
This control arm will undergo compression to 1.34 ATA for monoplace chambers and 2.4 ATA for multiplace chambers for the full 90-minute session but 21% oxygen instead of 100% oxygen being administered. These participants will also have two 5-10 minute "air breaks" to mimic the treatment protocol. Multiplace sham sessions will have modified air breaks to avoid decompression sickness. This will happen once a day for 5 days.
Hyperbaric Oxygen Therapy is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Hyperbaric Oxygen Therapy for:
- Decompression sickness
- Gas gangrene
- Carbon monoxide poisoning
- Wound healing
- Radiation injury
🇪🇺 Approved in European Union as Hyperbaric Oxygen Therapy for:
- Decompression sickness
- Gas gangrene
- Carbon monoxide poisoning
- Wound healing
- Radiation injury
- Diabetic foot ulcers
🇨🇦 Approved in Canada as Hyperbaric Oxygen Therapy for:
- Decompression sickness
- Gas gangrene
- Carbon monoxide poisoning
- Wound healing
- Radiation injury
🇯🇵 Approved in Japan as Hyperbaric Oxygen Therapy for:
- Decompression sickness
- Gas gangrene
- Carbon monoxide poisoning
- Wound healing
Find a clinic near you
Research locations nearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
University of Alabama MedicineBirmingham, AL
Northwestern Medicine Lake Forest HospitalLake Forest, IL
University of LouisvilleLouisville, KY
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study. [2013]Complementary therapy options are needed in the treatment of active ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) has been shown to have positive effects in experimental models of colitis and perianal Crohn's disease.
Systematic review: The safety and efficacy of hyperbaric oxygen therapy for inflammatory bowel disease. [2018]Hyperbaric oxygen therapy (HBOT) provides 100% oxygen under pressure, which increases tissue oxygen levels, relieves hypoxia and alters inflammatory pathways. Although there is experience using HBOT in Crohn's disease and ulcerative colitis, the safety and overall efficacy of HBOT in inflammatory bowel disease (IBD) is unknown.
Hyperbaric oxygen therapy stimulates colonic stem cells and induces mucosal healing in patients with refractory ulcerative colitis: a prospective case series. [2018]Hyperbaric oxygen (HBO) is used as part of treatment in a variety of clinical conditions. Its use in the treatment of ulcerative colitis has been reported in few clinical reports.
Hyperbaric oxygen therapy is well tolerated and effective for ulcerative colitis patients hospitalized for moderate-severe flares: a phase 2A pilot multi-center, randomized, double-blind, sham-controlled trial. [2021]Hyperbaric oxygen therapy (HBOT) markedly increases tissue oxygen delivery. Case series suggest it may have a potential therapeutic benefit in ulcerative colitis (UC). We investigated the therapeutic potential of HBOT as an adjunct to steroids for UC flares requiring hospitalization.
Hyperbaric Oxygen for Hospitalized patients with Ulcerative Colitis. [2019]One quarter of patients with ulcerative colitis will develop a severe acute exacerbation of disease during their lifetime. Despite high dose corticosteroids, half of these patients will fail subsequent medical rescue therapy, and half will require colectomy within 5 years. Dulai and colleagues report the results of a fascinating, double blind, sham controlled, proof of concept trial which demonstrated that administration of short term hyperbaric oxygen therapy (HBOT) at the point of presentation with severe UC was able to rapidly induce short term remission and avoid the need for urgent second line medical rescue therapy. Further dose finding studies are underway.
A Microsimulation Model to Project the 5-Year Impact of Using Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Acute Flares. [2022]Hyperbaric oxygen therapy (HBOT) improves short-term outcomes for ulcerative colitis (UC) patients hospitalized for acute flares. Longer-term impacts and cost-effectiveness are unknown.
Efficacy and safety evaluation of hyperbaric oxygen therapy for patients with ulcerative colitis: A protocol of systematic review and meta-analysis. [2023]Ulcerative colitis (UC) belongs to chronic colitis whose etiology and pathogenesis still have remained unclear. Hyperbaric oxygen therapy (HBOT) has been demonstrated to be effective for UC therapy. Still, evidence of its efficacy and safety is inconclusive. The purpose of the protocol is to evaluate the efficacy and safety of HBOT in UC therapy.