Hyperbaric oxygen therapy for ulcerative colitis patients hospitalized for moderate to severe flares: a phase 3 multi-center, randomized, double-blind, sham-controlled trial

Active Cooperative Agreement Awarded Last action

Award ID
U01DK134321
Recipient
Awarding agency
Obligated
$21,748,703

Award facts

Completion date 73% complete
Originally
Place of performance
Chicago, IL 60611, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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 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.

Transactions

Action Obligated Date
Amendment $2,478,728
Amendment $2,464,155
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Amendment $147,849
Amendment $2,217,740
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Amendment $2,439,584
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Original award $2,439,584
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Subawards

Subrecipient Amount Awarded
The Research Foundation For The State University Of New York Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind,… $74,000
Allegheny Singer Research Institute $85,214
Mayo Clinic $98,559
The Research Foundation For The State University Of New York $69,875
Yale Univ Long-Term Impact of the COVID-19 Pandemic on Self-Management of Chronic Conditions: The C3 Study $30,644
Mayo Clinic Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind,… $89,200
University Of Alabama At Birmingham $89,200
University Of Miami $59,600
The Trustees Of The University Of Pennsylvania $29,600
Orlando Health, Inc. $29,600
The Trustees Of The University Of Pennsylvania Hyperbaric Oxygen Therapy for Ulcerative Colitis P $57,528
University Of Louisville Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind,… $29,600
Weill Medical College Of Cornell University $29,600
Allegheny Singer Research Institute $49,000
University Of California, San Diego $64,789
Dartmouth-Hitchcock Clinic $58,800
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $29,600
The General Hospital Corporation $15,000
The Research Foundation For The State University Of New York $29,600
University Of California, LOS Angeles $29,600
University Of Miami $58,800
University Of Alabama At Birmingham $36,600
Orlando Health, Inc. $29,600
Mayo Clinic $88,200
Allegheny Singer Research Institute $35,200
Mayo Clinic $116,800
University Of Pittsburgh - Of The Commonwealth System Of Higher Education $29,600
Rector & Visitors Of The University Of Virginia $36,600
The General Hospital Corporation $36,600
University Of California, LOS Angeles $36,600
Dartmouth-Hitchcock Clinic $39,595
The Research Foundation For The State University Of New York $36,600
Allegheny Singer Research Institute $36,600
University Of Miami $36,600
University Of Louisville $46,500
Weill Medical College Of Cornell University $39,500
Dartmouth-Hitchcock Clinic $29,600
University Of Alabama At Birmingham $36,600
Mayo Clinic $29,600
University Of California, San Diego $64,778
Oregon Health & Science University $36,600
Orlando Health, Inc. $36,600
Rector & Visitors Of The University Of Virginia Hyperbaric Oxygen Therapy for Ulcerative Colitis P $39,500
Rector & Visitors Of The University Of Virginia Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Phase 3 Multi-Center, Randomized, Double-Blind, Sham-… $3,950,000
University Of Pittsburgh - Of The Commonwealth System Of Higher Education HyperbaricOxygenTherapyforUlcerativeColitisPatientsHospitalizedforModeratetoSevereFlares:APhase3Multi-Center, Randomized, Double-Blind, Sham-ControlledTrial $39,500
University Of Louisville $39,500
University Of Alabama At Birmingham $39,500
Weill Medical College Of Cornell University HyperbaricOxygenTherapyforUlcerativeColitisPatientsHospitalizedforModeratetoSevereFlares:APhase3Multi-Center, Randomized, Double-Blind, Sham-ControlledTria $39,500
Dartmouth-Hitchcock Clinic Hyperbaric Oxygen Therapy for Ulcerative Colitis P $39,500
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Quick answers

Who received award U01DK134321?

U01DK134321 was awarded to Northwestern University by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on March 15, 2023.

How much is award U01DK134321 worth?

$21,748,703 has been obligated on U01DK134321.

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