Hyperbaric Oxygen Therapy for Ulcerative Colitis

(HBOT-UC Trial)

Recruiting at 19 trial locations

Overseen By Mary Beth Tull, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must be taking: Intravenous steroids

Must not be taking: Biologics, small molecules

Disqualifiers: Crohn's colitis, Toxic megacolon, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 week

126 Participants Needed

What You Need to Know Before You Apply

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must be able to receive intravenous steroids and cannot start new biologic or small molecule treatments during hospitalization before randomization.

Is hyperbaric oxygen therapy safe for humans?

Research suggests that hyperbaric oxygen therapy (HBOT) is generally well tolerated in humans, including those with ulcerative colitis, although comprehensive safety data is still being evaluated. ^{1 2 3 4 5}

How is hyperbaric oxygen therapy different from other treatments for ulcerative colitis?

Hyperbaric oxygen therapy (HBOT) is unique because it involves breathing pure oxygen in a pressurized room, which increases oxygen delivery to tissues and can stimulate healing. Unlike standard treatments that often involve medications, HBOT is a non-drug therapy that has shown potential to rapidly induce remission in severe cases of ulcerative colitis, potentially avoiding the need for more aggressive medical interventions. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Hyperbaric Oxygen Therapy for Ulcerative Colitis?

Research shows that Hyperbaric Oxygen Therapy (HBOT) can help patients with ulcerative colitis by increasing oxygen delivery to tissues, which may aid in healing. Some studies found that HBOT can quickly reduce symptoms and help avoid more aggressive treatments, although more research is needed to understand its long-term benefits. ^{1 2 5 6 7}

Who Is on the Research Team?

Lauren Balmert Bonner, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am hospitalized for a severe flare-up of ulcerative colitis.

I agree to start HBOT within 48 hours after beginning IV steroids.

Exclusion Criteria

I need surgery urgently due to a complication.

I have been diagnosed with toxic megacolon.

I have been diagnosed with a specific type of colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Hyperbaric Oxygen Therapy (HBOT) or Sham Hyperbaric Air once a day for 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical response and remission

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy
• Sham Hyperbaric Air

Trial Overview 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.

How Is the Trial Designed?

Group I: Hyperbaric Oxygen Therapy Experimental Treatment 1 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 Air Placebo Group 1 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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a small study of 18 hospitalized patients with moderate-severe ulcerative colitis, those receiving hyperbaric oxygen therapy (HBOT) alongside steroids achieved a significantly higher clinical remission rate at day 5 compared to those receiving sham treatment (50% vs. 0%).

HBOT-treated patients also showed a lower need for progression to second-line therapies, such as colectomy or biologic therapy, during hospitalization (10% vs. 63%), indicating a potential therapeutic benefit without serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Dulai, PS., Buckey, JC., Raffals, LE., et al.[2021]

Hyperbaric oxygen therapy (HBOT) significantly reduces the risk of re-hospitalization, need for rescue medical therapy, and colectomy by over 60%, and decreases mortality by over 30% in ulcerative colitis patients hospitalized for acute flares, based on a model of 100,000 individuals over 5 years.

Although HBOT incurs an additional cost of $5600, it provides a higher quality-adjusted life year (QALY) yield, making it cost-effective at $43,000/QALY, and is projected to be more cost-effective than standard care in 95% of simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Microsimulation Model to Project the 5-Year Impact of Using Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Acute Flares. Dulai, PS., Jairath, V.[2022]

A proof of concept trial showed that short-term hyperbaric oxygen therapy (HBOT) can rapidly induce remission in patients with severe ulcerative colitis, potentially reducing the need for urgent medical rescue therapy.

This study highlights the potential of HBOT as a novel treatment option for severe acute exacerbations of ulcerative colitis, especially since many patients do not respond to high-dose corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen for Hospitalized patients with Ulcerative Colitis. Jairath, V.[2019]

Hyperbaric oxygen therapy (HBOT) significantly improved symptoms in patients with refractory ulcerative colitis, reducing stool frequency from an average of seven motions per day to just one by the 40th treatment cycle.

Histopathological analysis showed that HBOT not only improved clinical symptoms but also stimulated colonic stem cells, promoting healing in the colonic mucosa, as indicated by increased cell proliferation and reduced disease activity scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy stimulates colonic stem cells and induces mucosal healing in patients with refractory ulcerative colitis: a prospective case series. Bekheit, M., Baddour, N., Katri, K., et al.[2018]

In a prospective randomized open-label study comparing hyperbaric oxygen therapy (HBOT) plus conventional treatment to conventional treatment alone for active ulcerative colitis, no significant differences were found in clinical outcomes, including Mayo score and laboratory tests, among the assessed variables.

The study concluded that HBOT does not provide additional benefits in treating severe ulcerative colitis, suggesting it may not be a viable complementary therapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study. Pagoldh, M., Hultgren, E., Arnell, P., et al.[2013]

Hyperbaric oxygen therapy (HBOT) showed an overall response rate of 86% in treating inflammatory bowel disease (IBD), with 100% response in ulcerative colitis patients who had endoscopic follow-up, indicating its potential efficacy.

The treatment was found to be relatively safe, with a lower rate of adverse events compared to other uses of HBOT, suggesting it could be a viable option for patients with Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review: The safety and efficacy of hyperbaric oxygen therapy for inflammatory bowel disease. Dulai, PS., Gleeson, MW., Taylor, D., et al.[2018]

This systematic review aims to evaluate the efficacy and safety of hyperbaric oxygen therapy (HBOT) for treating ulcerative colitis (UC), addressing the unclear etiology and pathogenesis of the disease.

The study will analyze data from multiple databases and assess clinical effectiveness as the primary outcome, providing reliable evidence on HBOT's role in UC therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety evaluation of hyperbaric oxygen therapy for patients with ulcerative colitis: A protocol of systematic review and meta-analysis. Wang, W., He, Y., Wen, D., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

A Microsimulation Model to Project the 5-Year Impact of Using Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Acute Flares. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Hyperbaric Oxygen for Hospitalized patients with Ulcerative Colitis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy stimulates colonic stem cells and induces mucosal healing in patients with refractory ulcerative colitis: a prospective case series. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy does not improve the effects of standardized treatment in a severe attack of ulcerative colitis: a prospective randomized study. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Systematic review: The safety and efficacy of hyperbaric oxygen therapy for inflammatory bowel disease. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety evaluation of hyperbaric oxygen therapy for patients with ulcerative colitis: A protocol of systematic review and meta-analysis. [2023]