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

NCT07257588 | Enrolling By Invitation

• 1 other identifier: XJS20242001-C-1
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute severe ulcerative colitis; Refractory inflammatory bowel disease; Heperbaric oxygen-assisted treatment; Randomized controlled study

Outcome Measures

Primary Outcomes (1)

• Clinical response

  The Mayo score (or partial Mayo score) decreased by at least 3 points or more compared to the baseline (before treatment), or decreased by at least 30% from the baseline level. The single-item bleeding score decreased by at least 1 point and the absolute score was ≤ 1.

  7 days after treatment starts

Secondary Outcomes (3)

• Clinical remission

  7 days after treatment starts

• Endoscopic response

  7 days after treatment starts

• Endoscopic remission

  7 days after treatment starts

Study Arms (2)

Heperbaric oxygen-assisted Treatment

ACTIVE COMPARATOR

During the 7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day, hyperbaric oxygen therapy was also provided. The procedure was as follows: 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)

Drug: Administration of methylprednisolone sodium succinate; Procedure: Hyperbaric Oxygen Therapy

Control Treatment

OTHER

the 7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day

Drug: Administration of methylprednisolone sodium succinate

Interventions

Administration of methylprednisolone sodium succinate DRUG

7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day

Control Treatment; Heperbaric oxygen-assisted Treatment

Hyperbaric Oxygen Therapy PROCEDURE

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)

Heperbaric oxygen-assisted Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• According to the diagnostic criteria for ulcerative colitis in the 2018 national consensus opinion on the diagnosis and treatment of inflammatory bowel disease, it was confirmed as ulcerative colitis;
• According to the Truelove-witts standard, it was diagnosed as acute severe ulcerative colitis: the frequency of bloody stools per day is 6 times or more, and at the same time, one of the following systemic toxic manifestations is present: heart rate of 90 bpm, body temperature greater than 37.8℃, hemoglobin less than 105g/L, and erythrocyte sedimentation rate greater than 30mm/h;
• Age ≥ 18 years old;
• Patients who can and are willing to comply with the research protocol can provide a signed and dated written informed consent form.

You may not qualify if:

• Patients who may require immediate surgical treatment;
• Pregnant or lactating mothers;
• Patients with a score of ≥6 years old (TMM30/40/50) and \<6 points in the measurement of the Eustachian tube;
• Patients with a lung bulla larger than 2 cm at the lung apex or near the pleura in the chest plain scan;
• Patients with severe liver or kidney dysfunction, heart failure or other serious systemic diseases;
• Any situation that hinders the completion of the study or interferes with the analysis of the research results, including a history of drug or alcohol abuse, a smoker who has not quit, patients with mental illness or poor compliance, those with clear immune system (including HIV infection), blood system or tumor-related diseases;
• Patients who have withdrawn their informed consent;
• Patients who have participated in other clinical trials within 3 months before screening.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing hospital of digestive diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (12)

• Singh AK, Jha DK, Jena A, Kumar-M P, Sebastian S, Sharma V. Hyperbaric oxygen therapy in inflammatory bowel disease: a systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e564-e573. doi: 10.1097/MEG.0000000000002164.

  PMID: 33905214 BACKGROUND

• Glover LE, Colgan SP. Hypoxia and metabolic factors that influence inflammatory bowel disease pathogenesis. Gastroenterology. 2011 May;140(6):1748-55. doi: 10.1053/j.gastro.2011.01.056.

  PMID: 21530741 BACKGROUND

• Yamashita M, Yamashita M. Hyperbaric oxygen treatment attenuates cytokine induction after massive hemorrhage. Am J Physiol Endocrinol Metab. 2000 May;278(5):E811-6. doi: 10.1152/ajpendo.2000.278.5.E811.

  PMID: 10780936 BACKGROUND

• Wang Y, Chen D, Chen G. Hyperbaric oxygen therapy applied research in traumatic brain injury: from mechanisms to clinical investigation. Med Gas Res. 2014 Dec 4;4:18. doi: 10.1186/2045-9912-4-18. eCollection 2014.

  PMID: 25905012 BACKGROUND

• Memar MY, Yekani M, Alizadeh N, Baghi HB. Hyperbaric oxygen therapy: Antimicrobial mechanisms and clinical application for infections. Biomed Pharmacother. 2019 Jan;109:440-447. doi: 10.1016/j.biopha.2018.10.142. Epub 2018 Nov 3.

  PMID: 30399579 BACKGROUND

• Chen L, Wang Y, Zhou H, Liang Y, Zhu F, Zhou G. The new insights of hyperbaric oxygen therapy: focus on inflammatory bowel disease. Precis Clin Med. 2024 Jan 18;7(1):pbae001. doi: 10.1093/pcmedi/pbae001. eCollection 2024 Mar.

  PMID: 38344218 BACKGROUND

• Parigi TL, D'Amico F, Abreu MT, Dignass A, Dotan I, Magro F, Griffiths AM, Jairath V, Iacucci M, Mantzaris GJ, O'Morain C, Reinisch W, Sachar DB, Turner D, Yamamoto T, Rubin DT, Peyrin-Biroulet L, Ghosh S, Danese S. Difficult-to-treat inflammatory bowel disease: results from an international consensus meeting. Lancet Gastroenterol Hepatol. 2023 Sep;8(9):853-859. doi: 10.1016/S2468-1253(23)00154-1. Epub 2023 Jul 6.

  PMID: 37423233 BACKGROUND

• De Cristofaro E, Salvatori S, Marafini I, Zorzi F, Alfieri N, Musumeci M, Calabrese E, Monteleone G. Long-Term Risk of Colectomy in Patients with Severe Ulcerative Colitis Responding to Intravenous Corticosteroids or Infliximab. J Clin Med. 2022 Mar 18;11(6):1679. doi: 10.3390/jcm11061679.

  PMID: 35330005 BACKGROUND

• TRUELOVE SC, WITTS LJ. Cortisone in ulcerative colitis; final report on a therapeutic trial. Br Med J. 1955 Oct 29;2(4947):1041-8. doi: 10.1136/bmj.2.4947.1041. No abstract available.

  PMID: 13260656 BACKGROUND

• Gupta V, Mohsen W, Chapman TP, Satsangi J. Predicting Outcome in Acute Severe Colitis-Controversies in Clinical Practice in 2021. J Crohns Colitis. 2021 Jul 5;15(7):1211-1221. doi: 10.1093/ecco-jcc/jjaa265.

  PMID: 33388777 BACKGROUND

• Wehkamp J, Gotz M, Herrlinger K, Steurer W, Stange EF. Inflammatory Bowel Disease. Dtsch Arztebl Int. 2016 Feb 5;113(5):72-82. doi: 10.3238/arztebl.2016.0072.

  PMID: 26900160 BACKGROUND

• Dulai PS, Buckey JC Jr, Raffals LE, Swoger JM, Claus PL, O'Toole K, Ptak JA, Gleeson MW, Widjaja CE, Chang JT, Adler JM, Patel N, Skinner LA, Haren SP, Goldby-Reffner K, Thompson KD, Siegel CA. Hyperbaric oxygen therapy is well tolerated and effective for ulcerative colitis patients hospitalized for moderate-severe flares: a phase 2A pilot multi-center, randomized, double-blind, sham-controlled trial. Am J Gastroenterol. 2018 Oct;113(10):1516-1523. doi: 10.1038/s41395-018-0005-z. Epub 2018 Feb 16.

  PMID: 29453383 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: September 30, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)