NCT07257588

The Efficacy of Hyperbaric Oxygen-assisted Treatment for ASUC and Refractory IBD

Analysis of the Efficacy of Hyperbaric Oxygen-assisted Treatment for Acute Severe Ulcerative Colitis and Refractory Inflammatory Bowel Disease: A Randomized Controlled Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Department of Gastroenterology plans to conduct a randomized controlled study on the efficacy analysis of hyperbaric oxygen-assisted treatment for acute severe ulcerative colitis and refractory inflammatory bowel disease. The research design is a randomized, controlled study. The objective is to compare the clinical remission rate, clinical response rate, endoscopic remission rate, and endoscopic response rate between patients with acute severe ulcerative colitis (ASUC) and refractory inflammatory bowel disease (IBD) treated with hyperbaric oxygen therapy (HBOT) as an adjuvant and those treated with standard treatment regimens. This study aims to provide clear evidence for the use of HBOT as an adjuvant treatment for ASUC and refractory IBD.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Administration of methylprednisolone sodium succinate	7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
PROCEDURE	Hyperbaric Oxygen Therapy	1. Pressurization: It took 25 minutes to increase the pressure from 1ATA to 2.5ATA (without oxygen inhalation) 2. Stabilization: A total of 80 minutes (30 minutes of oxygen inhalation, 5 minutes of rest, 30 minutes of oxygen inhalation, 5 minutes of rest, 10 minutes of oxygen inhalation) 3. Decompression: 25 minutes (the first 18 minutes continued oxygen inhalation, and then 7 minutes of oxygen inhalation was stopped)

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: China