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NCT05987852 · ClinicalTrials.gov registry record · NA
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
A NA study of Ulcerative Colitis, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 13
- Study locations
NCT05987852: Recruiting NA study of Ulcerative Colitis, sponsored by Northwestern University.
NCT05987852 is a NA study of Ulcerative Colitis that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 126 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05987852, a NA study of Ulcerative Colitis, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Hyperbaric Oxygen Therapy
- OTHER Sham Hyperbaric Air
Study Locations (13)
Florida
- University of Miami Health - Miami
- Orlando Health - Orlando
New York
- Cornell University Medical Center - New York
- State University of New York Upstate Medical University - Syracuse
Pennsylvania
- Allegheny Health - Pittsburgh
- University of Pittsburgh Medical Center - Pittsburgh
Alabama
- University of Alabama Medicine - Birmingham
California
- University of Los Angeles Health - Los Angeles
Illinois
- Northwestern Medicine Lake Forest Hospital - Lake Forest
Kentucky
- University of Louisville - Louisville
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2024-01-09 |
| Est. Completion | 2027-09-01 |
| Phase | NA |
What NCT05987852 shows while recruiting
NCT05987852 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Hyperbaric Oxygen Therapy is the first listed.
NCT05987852 lists 13 locations in 10 states (Florida, New York, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05987852 about?
NCT05987852 is a clinical study titled "Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)". 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 demo...
What is the current status of trial NCT05987852?
This trial is currently recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2024-01-09. Estimated completion is 2027-09-01.
What conditions does trial NCT05987852 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT05987852?
The interventions under investigation include: Hyperbaric Oxygen Therapy (DEVICE), Sham Hyperbaric Air (OTHER).
Who is sponsoring clinical trial NCT05987852?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05987852 being conducted?
This trial has 13 study locations across Alabama, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05987852's enrollment target sits among peer trials
126 55th of 122 higher than 68 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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