Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)

Официальное название

Hyperbaric Oxygen Therapy for Ulcerative Colitis Patients Hospitalized for Moderate to Severe Flares: A Multi-Center, Randomized, Double-Blind, Sham-Controlled Trial

Обзор

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.

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• 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 [Срок оценки: Day 5]

Вторичные конечные точки (12)

• Clinical Response [Срок оценки: Day 3]
• Change in inflammation, as measured by C-reactive protein [Срок оценки: Day 3]
• Endoscopic response [Срок оценки: Day 5]
• Steroid-free, colectomy-free, clinical remission [Срок оценки: Day 90]
• Endoscopic Improvement [Срок оценки: Day 90]
• Endoscopic Remission [Срок оценки: Day 90]
• Mucosal Healing [Срок оценки: Day 90]
• Clinical Remission [Срок оценки: Day 5]
• Colectomy [Срок оценки: Day 90; 12 month]
• Re-hospitalization for ulcerative colitis flare [Срок оценки: 12 months]
• Numeric Urgency Rating Score [Срок оценки: Day 3]
• Serious Infections or Serious Adverse Events [Срок оценки: Day 5]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 13 центров

• University of Alabama Medicine — Birmingham
• University of Los Angeles Health — Los Angeles
• University of Miami Health — Miami
• Orlando Health — Orlando
• Northwestern Medicine Lake Forest Hospital — Lake Forest
• University of Louisville — Louisville
• Massachusetts General Hospital — Boston
• Mayo Clinic — Rochester
• … и ещё 5 центров

Публикации

• Bonner LB, Sadler C, Lindholm P, Scholtens DM, Dulai PS; HBOT-UC Consortium. Hyperbaric oxygen therapy for ulcerative colitis patients hospitalized for moderate to severe flares (HBOT-UC): study protocol for a multi-center, randomized, double-blind, sham-controlled trial. Trials. 2025 Jun 22;26(1):220. doi: 10.1186/s13063-025-08932-5. PMID 40545548
• Honap S, Jairath V, Sands BE, Dulai PS, Danese S, Peyrin-Biroulet L. Acute severe ulcerative colitis trials: the past, the present and the future. Gut. 2024 Sep 9;73(10):1763-1773. doi: 10.1136/gutjnl-2024-332489. PMID 38834296

Идентификаторы

NCT: NCT05987852 · HBOT-UC · 1U01DK134321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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