Hyperbaric oxygen for severe ulcerative colitis flares in the hospital
Official title: Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Funded at Northwestern University · NIH-11378296 · Data updated 2026-11-12
This trial gives hospitalized people with moderate-to-severe ulcerative colitis flares hyperbaric oxygen or a sham treatment to see if it speeds recovery and prevents surgery.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Northwestern University NIH-funded |
| Lab location | 1 site (Chicago, United States) |
| Project start | March 15, 2023 |
| Project end | February 29, 2028 |
| Funding year | 2026 |
| Award (this year) | $2,478,728 |
| NIH project number | 5U01DK134321-04 |
| Project ID | NIH-11378296 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are adults hospitalized for a moderate-to-severe ulcerative colitis flare who have not improved sufficiently with intravenous steroids.
✕Less likely to help
People with mild ulcerative colitis not requiring hospitalization, or those with contraindications to hyperbaric therapy (such as certain lung problems), are unlikely to benefit from this trial.
What this research studies
If you're hospitalized with a moderate-to-severe ulcerative colitis flare, this trial may offer sessions of hyperbaric oxygen—breathing 100% oxygen in a pressurized chamber—compared with a sham treatment. Participants are randomly assigned and neither you nor your care team will know which treatment you get (double-blind), and the trial runs at multiple hospitals. The goal is to reduce gut inflammation, lower inflammatory markers, and prevent progression to stronger drugs or colectomy. Researchers previously saw benefit in phase 2 trials and this larger phase 3 effort aims to confirm those findings in a broader inpatient population.
Why it matters
Potential benefit: If helpful, the treatment could reduce intestinal inflammation during flares and lower the chance of needing biologic drugs or colectomy.
How similar studies have gone: Earlier phase 2 trials reported improvements in disease activity, lower inflammatory markers, and fewer progressions to biologics or colectomy, so this phase 3 trial is a larger confirmatory test.
Where this research is happening
-
Northwestern University
Chicago, United States Active
Researchers
- Principal investigator: Dulai, Parambir Singh — Northwestern University
- Study coordinator: Dulai, Parambir Singh
Related research
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.