Back to resultsHyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Primary Purpose
Ulcerative Colitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sham Hyperbaric Air
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring hyperbaric oxygen therapy, HBOT, ulcerative colitis, hyperbaric oxygen
Eligibility Criteria
Inclusion Criteria: Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare Age 18-85 Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids Exclusion Criteria: Complication requiring urgent surgical intervention Toxic megacolon Inability to receive intravenous steroids Historically failed 3 or more classes of advanced therapeutic options Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis Received any investigational drug within 30 days Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicity Women who are pregnant or nursing Unwillingness to complete course of HBOT Active SARS CoV 2 infection
Sites / Locations
- University of Alabama Medicine
- University of Los Angeles Health
- University of Miami Health
- Orlando Health
- Lake Forest Hospital
- University of Louisville
- University of Maryland Medical Center
- Tufts Medical Center
- Massachusetts General Hospital
- Mayo Clinic
- Dartmouth Hitchcock Medical Center
- New York University Langone Health
- Cornell University Medical Center
- State University of New York Upstate Medical University
- Oregon Health & Science University Health
- Allegheny Health
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- University of Virginia Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Hyperbaric Oxygen Therapy
Sham Hyperbaric Air
Arm Description
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.
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.
Outcomes
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
Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.
Secondary Outcome Measures
Endoscopic Improvement
Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)
Endoscopic Remission
Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)
Histologic Remission
Proportion of participants achieving Histologic Remission (Geboes histology score ≤ 2)
Mucosal Healing
Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)
Clinical Remission
Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score > 1)
Initiation and/or adjustment of biologics or small molecule inhibitors
Proportion of participants who require initiation and/or adjustment in biologics or small molecule inhibitors, and number of biologics or small molecule inhibitors and/or adjustments required over 12 months
Colectomy
Proportion of participants requiring colectomy
Re-hospitalization
Proportion of participants with any re-hospitalization during the follow-up period
Serious Infections or Serious Adverse Events
Proportion of participants experiencing any serious infections or serious adverse events during intervention period
Number of new initiations and/or adjustments in biologics or small molecule inhibitors
Number of new initiations and/or adjustments in biologics or small molecule inhibitors
Duration of index hospitalization
Duration of index hospitalization
Number of re-hospitalizations
Number of re-hospitalizations
Change in inflammation, as measured by C-reactive protein
Change in inflammation, as measured by C-reactive protein
Change in inflammation, as measured by fecal calprotectin
Change in inflammation, as measured by fecal calprotectin
Full Mayo Score
Score ranges from 0-12 ; higher scores are worse
Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Score ranges from 0-8 ; higher scores are worse
Numeric Urgency Rating Score
Score ranges from 0-10 ; higher scores are worse
Improvement in individual Mayo sub-score for stool frequency
Score ranges from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Improvement in individual Mayo sub-score for rectal bleeding
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Improvement in individual Mayo Endoscopic sub-score for mucosal appearance at endoscopy
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Improvement in individual Mayo sub-score for physician rating of disease activity
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Improvement in urgency Simple Clinical Colitis Activity Index (SCCAI) sub-score
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Improvement in nocturnal bowel movement frequency Simple Clinical Colitis Activity Index (SCCAI) sub-score
Scores range from 0-2 ; higher scores are worse ; improvement defined as decrease in score from baseline
Full Information
NCT ID
NCT05987852
First Posted
August 1, 2023
Last Updated
October 3, 2023
Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05987852
Brief Title
Hyperbaric Oxygen Therapy for Ulcerative Colitis
Acronym
HBOT-UC
Official Title
Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue oxygenation. Two small prospective randomized controlled trials have demonstrated that the delivery of HBOT to UC patients hospitalized for acute moderate to severe flares results in improved remission rates and avoidance of in-hospital progression to biologics, small molecules, or colectomy. In this larger trial the study aims to confirm the treatment benefits of HBOT for hospitalized UC patients and study the immune-microbe mechanisms underpinning treatment response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
hyperbaric oxygen therapy, HBOT, ulcerative colitis, hyperbaric oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
5-day intervention period; 12 months observational period through standard of care visits and follow-up
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric Oxygen Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Hyperbaric Air
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Hyperbaric Air
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Proportion of participants achieving clinical response as measured by complete resolution of rectal bleeding (Mayo rectal bleeding sub-score of 0) and improvement in stool frequency (at least 1 point reduction in Mayo stool frequency sub-score), without the need for in-hospital biologics, small molecules, or colectomy, by study day 5.
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Endoscopic Improvement
Description
Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)
Time Frame
Day 5; Day 90
Title
Endoscopic Remission
Description
Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)
Time Frame
Day 5; Day 90
Title
Histologic Remission
Description
Proportion of participants achieving Histologic Remission (Geboes histology score ≤ 2)
Time Frame
Day 5; Day 90
Title
Mucosal Healing
Description
Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2)
Time Frame
Day 5; Day 90
Title
Clinical Remission
Description
Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score > 1)
Time Frame
Day 3; Day 5; 12 months
Title
Initiation and/or adjustment of biologics or small molecule inhibitors
Description
Proportion of participants who require initiation and/or adjustment in biologics or small molecule inhibitors, and number of biologics or small molecule inhibitors and/or adjustments required over 12 months
Time Frame
12 months
Title
Colectomy
Description
Proportion of participants requiring colectomy
Time Frame
Day 5; 12 months
Title
Re-hospitalization
Description
Proportion of participants with any re-hospitalization during the follow-up period
Time Frame
12 months
Title
Serious Infections or Serious Adverse Events
Description
Proportion of participants experiencing any serious infections or serious adverse events during intervention period
Time Frame
Day 5
Title
Number of new initiations and/or adjustments in biologics or small molecule inhibitors
Description
Number of new initiations and/or adjustments in biologics or small molecule inhibitors
Time Frame
12 months
Title
Duration of index hospitalization
Description
Duration of index hospitalization
Time Frame
From date of hospitalization to time of discharge, assessed up to 30 days
Title
Number of re-hospitalizations
Description
Number of re-hospitalizations
Time Frame
12 months
Title
Change in inflammation, as measured by C-reactive protein
Description
Change in inflammation, as measured by C-reactive protein
Time Frame
Day 3; Day 5
Title
Change in inflammation, as measured by fecal calprotectin
Description
Change in inflammation, as measured by fecal calprotectin
Time Frame
Day 5
Title
Full Mayo Score
Description
Score ranges from 0-12 ; higher scores are worse
Time Frame
Day 5; Day 90
Title
Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Description
Score ranges from 0-8 ; higher scores are worse
Time Frame
Day 5; Day 90
Title
Numeric Urgency Rating Score
Description
Score ranges from 0-10 ; higher scores are worse
Time Frame
Day 3; Day 5
Title
Improvement in individual Mayo sub-score for stool frequency
Description
Score ranges from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Time Frame
Day 3; Day 5
Title
Improvement in individual Mayo sub-score for rectal bleeding
Description
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Time Frame
Day 3; Day 5
Title
Improvement in individual Mayo Endoscopic sub-score for mucosal appearance at endoscopy
Description
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Time Frame
Day 5
Title
Improvement in individual Mayo sub-score for physician rating of disease activity
Description
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Time Frame
Day 3; Day 5
Title
Improvement in urgency Simple Clinical Colitis Activity Index (SCCAI) sub-score
Description
Scores range from 0-3 ; higher scores are worse ; improvement defined as decrease in score from baseline
Time Frame
Day 3; Day 5
Title
Improvement in nocturnal bowel movement frequency Simple Clinical Colitis Activity Index (SCCAI) sub-score
Description
Scores range from 0-2 ; higher scores are worse ; improvement defined as decrease in score from baseline
Time Frame
Day 3; Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare
Age 18-85
Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids
Exclusion Criteria:
Complication requiring urgent surgical intervention
Toxic megacolon
Inability to receive intravenous steroids
Historically failed 3 or more classes of advanced therapeutic options
Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis
Received any investigational drug within 30 days
Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment that increases the risk for HBOT toxicity
Women who are pregnant or nursing
Unwillingness to complete course of HBOT
Active SARS CoV 2 infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Pina, BS
Phone
312-503-6459
Email
yasmin.pina@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Beth Tull, MS
Phone
312-503-4746
Email
mary.tull@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Balmert Bonner, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirk Russ, MD
Email
kruss@uabmc.edu
Facility Name
University of Los Angeles Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Sauk, MD
Email
jsauk@mednet.ucla.edu
Facility Name
University of Miami Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oriana Mazorra, MD
Email
omazorra@med.miami.edu
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udayakumar Navaneethan, MD
Email
udayakumar.navaneethan@orlandohealth.com
Facility Name
Lake Forest Hospital
City
Lake Forest
State/Province
Illinois
ZIP/Postal Code
60045
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paramir S Dulai, MD
Email
parambir.dulai@northwestern.edu
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Dryden, MD
Email
tad.dryden@louisville.edu
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Cross, MD
Email
rcross@som.umaryland.edu
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilani Perera, MD
Email
perera.lilani@icloud.com
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashwin Ananthakrishnan, MD
Email
aananthakrishnan@mgh.harvard.edu
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Raffals, MD
Email
raffals.laura@mayo.edu
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corey Siegel, MD
Email
corey.a.siegel@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Michael Winter, MD
Email
michael.w.winter@hitchcock.org
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hudesman, MD
Email
david.hudesman@nyulangone.org
Facility Name
Cornell University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Lukin, MD
Email
djl9010@med.cornell.edu
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marvin Heyboer, MD
Email
HeyboerM@upstate.edu
Facility Name
Oregon Health & Science University Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Sofia, MD
Email
sofia@ohsu.edu
Facility Name
Allegheny Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gursimran Kochhar, MD
Email
gursimran.kochhar@ahn.org
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Dueker, MD
Email
duekerjm@upmc.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Forster, MD
Email
forstere@musc.edu
Facility Name
University of Virginia Health
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Tuskey, MD
Email
agt2w@hscmail.mcc.virginia.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.
Learn more about this trial
Hyperbaric Oxygen Therapy for Ulcerative Colitis
We'll reach out to this number within 24 hrs