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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DK134321 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen Therapy | Experimental | 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. |
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| Sham Hyperbaric Air | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Sum of Mayo rectal bleeding and stool frequency sub-scores (Key secondary endpoint) | Day 3 |
| Change in inflammation, as measured by C-reactive protein | Change in inflammation, as measured by C-reactive protein (Key secondary endpoint) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmin Pina, BS | Contact | 312-503-6459 | yasmin.pina@northwestern.edu | |
| Mary Beth Tull, MS | Contact | 312-503-4746 | mary.tull@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Balmert Bonner, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Medicine | Recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40545548 | Derived | 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. | |
| 38834296 | Derived | 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. |
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Dataset with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Repository.
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5-day intervention period; 12 months observational period through standard of care visits and follow-up
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| Sham Hyperbaric Air | Other | 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. |
|
| Day 3 |
| Endoscopic response | Ulcerative Colitis Endoscopic Index of Severity (UCEIS) (Key secondary endpoint) | Day 5 |
| Steroid-free, colectomy-free, clinical remission | Proportion of participants steroid-free, colectomy-free, and with clinical remission (Full Mayo ≤ 2, with no sub-score > 1) | Day 90 |
| Endoscopic Improvement | Proportion of participants achieving endoscopic improvement (Mayo endoscopic sub-score of 0 or 1) | Day 90 |
| Endoscopic Remission | Proportion of participants achieving Endoscopic remission (Mayo endoscopic sub-score of 0) | Day 90 |
| Mucosal Healing | Proportion of participants achieving Mucosal Healing (Endoscopic sub-score 0 or 1 + Geboes histology score ≤ 2) | Day 90 |
| Clinical Remission | Proportion of participants achieving clinical remission (Full Mayo ≤ 2, with no sub-score > 1) | Day 5 |
| Colectomy | Proportion of participants requiring colectomy | Day 90; 12 month |
| Re-hospitalization for ulcerative colitis flare | Proportion of participants with re-hospitalization during the follow-up period for ulcerative colitis flare | 12 months |
| Numeric Urgency Rating Score | Score ranges from 0-10 ; higher scores are worse | Day 3 |
| Serious Infections or Serious Adverse Events | Proportion of participants experiencing any serious infections or serious adverse events during intervention period | Day 5 |
| University of Los Angeles Health | Recruiting | Los Angeles | California | 90024 | United States |
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| University of Miami Health | Recruiting | Miami | Florida | 33136 | United States |
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| Orlando Health | Recruiting | Orlando | Florida | 32806 | United States |
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| Northwestern Medicine Lake Forest Hospital | Recruiting | Lake Forest | Illinois | 60045 | United States |
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| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Dartmouth Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
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| Cornell University Medical Center | Active, not recruiting | New York | New York | 10065 | United States |
| State University of New York Upstate Medical University | Recruiting | Syracuse | New York | 13210 | United States |
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| Allegheny Health | Recruiting | Pittsburgh | Pennsylvania | 15090 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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