Hyperbaric Oxygen Therapy for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987852
• Other study ID #: HBOT-UC
• Secondary ID: 1U01DK134321
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Yasmin Pina, BS
• Phone: 312-503-6459
• Email: yasmin.pina[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Hyperbaric Oxygen Therapy
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.

Other:
• Sham Hyperbaric Air
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.

Locations

Country	Name	City	State
United States	University of Alabama Medicine	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Virginia Health	Charlottesville	Virginia
United States	Northwestern Medicine Lake Forest Hospital	Lake Forest	Illinois
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Los Angeles Health	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Miami Health	Miami	Florida
United States	Cornell University Medical Center	New York	New York
United States	Orlando Health	Orlando	Florida
United States	Allegheny Health	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University Health	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	State University of New York Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 5
Secondary	Endoscopic Improvement	Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1)	Day 5; Day 90
Secondary	Endoscopic Remission	Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0)	Day 5; Day 90
Secondary	Histologic Remission	Proportion of participants achieving Histologic Remission (Geboes histology score = 2)	Day 5; Day 90
Secondary	Mucosal Healing	Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score = 2)	Day 5; Day 90
Secondary	Clinical Remission	Proportion of participants achieving clinical remission (Full Mayo = 2, with no sub-score > 1)	Day 3; Day 5; 12 months
Secondary	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	12 months
Secondary	Colectomy	Proportion of participants requiring colectomy	Day 5; 12 months
Secondary	Re-hospitalization	Proportion of participants with any re-hospitalization during the follow-up period	12 months
Secondary	Serious Infections or Serious Adverse Events	Proportion of participants experiencing any serious infections or serious adverse events during intervention period	Day 5
Secondary	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	12 months
Secondary	Duration of index hospitalization	Duration of index hospitalization	From date of hospitalization to time of discharge, assessed up to 30 days
Secondary	Number of re-hospitalizations	Number of re-hospitalizations	12 months
Secondary	Change in inflammation, as measured by C-reactive protein	Change in inflammation, as measured by C-reactive protein	Day 3; Day 5
Secondary	Change in inflammation, as measured by fecal calprotectin	Change in inflammation, as measured by fecal calprotectin	Day 5
Secondary	Full Mayo Score	Score ranges from 0-12 ; higher scores are worse	Day 5; Day 90
Secondary	Ulcerative Colitis Endoscopic Index of Severity (UCEIS)	Score ranges from 0-8 ; higher scores are worse	Day 5; Day 90
Secondary	Numeric Urgency Rating Score	Score ranges from 0-10 ; higher scores are worse	Day 3; Day 5
Secondary	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	Day 3; Day 5
Secondary	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	Day 3; Day 5
Secondary	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	Day 5
Secondary	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	Day 3; Day 5
Secondary	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	Day 3; Day 5
Secondary	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	Day 3; Day 5