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

> **NIH NIH U34** · NORTHWESTERN UNIVERSITY · 2021 · $346,500

## Abstract

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. 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, phase 3 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) immune 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:** 10592029
- **Project number:** 7U34DK126626-02
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Lauren Balmert Bonner
- **Activity code:** U34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $346,500
- **Award type:** 7
- **Project period:** 2021-09-06 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10592029

## Citation

> US National Institutes of Health, RePORTER application 10592029, Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham Controlled Trial (HBOT-UC) (7U34DK126626-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10592029. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*