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Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC Trial)

N/A

Recruiting

Led By Lauren Balmert Bonner, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial aims to confirm if hyperbaric oxygen therapy can improve remission and reduce surgery for ulcerative colitis patients in hospital. It also looks at how it impacts immune and microbial functions.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of HBOT may include ear pain or damage due to increased pressure, temporary vision changes, fatigue and claustrophobia from being inside the chamber. Rarely it can cause lung collapse or seizures from too much oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical response defined as complete resolution of rectal bleeding and improvement in stool frequency, without need for in-hospital biologics, small molecules, or colectomy by study day 5

Secondary study objectives

Change in inflammation, as measured by C-reactive protein

Change in inflammation, as measured by fecal calprotectin

Clinical Remission

+20 more

Side effects data

From 2018 Phase 2 trial • 20 Patients • NCT02363959

10%

Repeat bronchoscopy due to bleeding during biopsy

100%

80%

60%

40%

20%

Study treatment Arm

Hyperbaric Oxygen, Airway Biopsy

No Hyperbaric Oxygen, Airway Biopsy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hyperbaric Oxygen TherapyExperimental Treatment1 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 AirPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hyperbaric Oxygen Therapy

2016

Completed Phase 4

~800

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