# Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial

> **NIH NIH U01** · NORTHWESTERN UNIVERSITY · 2024 · $2,365,589

## Abstract

PROJECT SUMMARY
Ulcerative colitis is one of the most expensive medical conditions in the United States, with a considerable
amount of these costs being incurred during hospitalizations for acute flares. A substantial proportion of
ulcerative colitis patients hospitalized for acute flares will fail to respond to intravenous steroids and
require second line therapies such as biologics and/or colectomy, which can be associated with significant
morbidity and mortality. Ulcerative colitis patients who are hospitalized or have recently been hospitalized
for acute flares are excluded from traditional phase 2 and 3 drug development trials because of how high
risk they are for progression to colectomy or re-admission. Novel, safe, and effective treatments are
needed to optimize outcomes in this high-risk orphan population. A hallmark of ulcerative colitis is chronic
intestinal mucosal hypoxia and inflammation, with an accompanying dysfunction in hypoxia response
pathways and preferential activation of pathogenic immune cells including neutrophils. Hyperbaric oxygen
therapy involves breathing 100% oxygen under increased atmospheric pressure to increase tissue
oxygenation. In a phase 2 trial program we demonstrated that this increased oxygenation of mucosal
tissue leads to improvements in disease activity in ulcerative colitis, reductions in inflammatory markers,
and prevention of progression to biologics or colectomy during hospitalizations for acute flares. In the
current proposal we aim to 1) confirm the impact of hyperbaric oxygen therapy on disease outcomes in
ulcerative colitis patients hospitalized for acute flares through a multi-center, double-blind, sham-
controlled, clinical trial. We further aim to explore the mechanisms through which hyperbaric oxygen
therapy improves disease activity by studying the hyperbaric oxygen specific effects on 2) neutrophils and
epithelial cells, and 3) the microbiome. Confirmation of treatment efficacy for hyperbaric oxygen therapy
would bring forward a novel therapy for a high-risk population of ulcerative colitis patients who are
traditionally excluded from traditional clinical trial programs, while also advancing our understanding of
disease pathogenesis and the interplay between hypoxia, the immune system, and the microbiome.

## Key facts

- **NIH application ID:** 10805372
- **Project number:** 5U01DK134321-02
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Lauren Balmert Bonner
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $2,365,589
- **Award type:** 5
- **Project period:** 2023-03-15 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10805372

## Citation

> US National Institutes of Health, RePORTER application 10805372, Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial (5U01DK134321-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10805372. Licensed CC0.

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