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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
Awards & highlights
HBOT-UC Trial 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.Check my eligibility
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.See study design
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.
HBOT-UC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in inflammation, as measured by C-reactive protein
Change in inflammation, as measured by fecal calprotectin
Clinical Remission
+20 moreSide effects data
From 2018 Phase 2 trial • 20 Patients • NCT0236395910%
Repeat bronchoscopy due to bleeding during biopsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hyperbaric Oxygen, Airway Biopsy
No Hyperbaric Oxygen, Airway Biopsy
HBOT-UC 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
~720
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
916,961 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
1,355 Patients Enrolled for Ulcerative Colitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,466 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
2,026 Patients Enrolled for Ulcerative Colitis
Lauren Balmert Bonner, PhDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery urgently due to a complication.I have been diagnosed with toxic megacolon.I have been diagnosed with a specific type of colitis.I have tried and not responded to 3 or more types of advanced cancer treatments.I cannot receive steroids through an IV.I have a serious heart, kidney, nerve, hormone, lung, or liver condition that could make HBOT risky for me.I am between 18 and 85 years old.I am currently infected with COVID-19.I am not willing to complete a course of hyperbaric oxygen therapy.I am hospitalized for a severe flare-up of ulcerative colitis.I am not pregnant or nursing.I agree to start HBOT within 48 hours after beginning IV steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Hyperbaric Oxygen Therapy
- Group 2: Sham Hyperbaric Air
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who can qualify to join this research project?
"Individuals between the age of 18 and 85, with a diagnosis of ulcerative colitis, may be eligible for this trial. 126 people are needed to complete this research study in full."
Answered by AI
Are there any opportunities for eligible individuals to partake in this research?
"As indicated by the clinicaltrials.gov database, this medical trial is not actively recruiting patients; however, it was initially posted on September 15th 2023 and last edited August 9th 2023. Despite its inactivity, there are still plenty of other trials seeking participants at present amounting to 410 different research studies."
Answered by AI
Is this trial open to individuals who are over two decades of age?
"The upper and lower age limits of this clinical study are 18 to 85 years old. For those younger than the minimum requirement, there are 75 studies available for consideration, whereas 347 trials accommodate individuals over 65."
Answered by AI
What is the current tally of hospitals engaged in this trial?
"The research team is enrolling participants at University of Los Angeles Health in Los Angeles, California; University of Miami Health in Miami, Florida; Orlando Health in Orlando, Illinois as well as 19 other sites."
Answered by AI
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