Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 17
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with known or newly diagnosed UC who require hospitalization for an acute moderate to severe flare
- •Age 18-85
- •Able to fully participate in all aspects of the trial
- •Consented and able to receive first HBOT session within first 48 hours of initiation of intravenous steroids
- •Agreement to not participate in another trial for the duration of the active intervention period
排除标准
- •Received hyperbaric oxygen therapy either as part of standard of care or through a clinical trial prior to enrollment
- •Complication requiring urgent surgical intervention
- •Requirement for new start of a biologic or small molecule during the hospitalization prior to randomization and/or anticipated requirement for rescue medical or surgical therapy within 48 hours of randomization
- •Toxic megacolon
- •Inability to receive intravenous steroids
- •Historically failed or been exposed to 4 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
研究组 & 干预措施
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.
干预措施: Sham Hyperbaric Air (Other)
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.
干预措施: Hyperbaric Oxygen Therapy (Device)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Endoscopic response(Day 5)
- Mucosal Healing(Day 90)
- Clinical Remission(Day 5)
- Colectomy(Day 90; 12 month)
- Clinical Response(Day 3)
- Change in inflammation, as measured by C-reactive protein(Day 3)
- Endoscopic Remission(Day 90)
- Steroid-free, colectomy-free, clinical remission(Day 90)
- Endoscopic Improvement(Day 90)
- Re-hospitalization for ulcerative colitis flare(12 months)
- Numeric Urgency Rating Score(Day 3)
- Serious Infections or Serious Adverse Events(Day 5)
研究者
Lauren C Balmert
Professor
Northwestern University