The Efficacy of Hyperbaric Oxygen-assisted Treatment for ASUC and Refractory IBD
NCT ID: NCT07257588
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
44 participants
INTERVENTIONAL
2024-09-30
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Heperbaric oxygen-assisted Treatment
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)
Administration of methylprednisolone sodium succinate
7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
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)
Control Treatment
the 7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
Administration of methylprednisolone sodium succinate
7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
Interventions
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Administration of methylprednisolone sodium succinate
7-day continuous intravenous administration of methylprednisolone sodium succinate at a dose of 40mg per day
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)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Xijing Hospital of Digestive Diseases
OTHER
Responsible Party
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Jie Liang
Professor
Locations
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Xijing hospital of digestive diseases
Xi'an, Shaanxi, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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XJS20242001-C-1
Identifier Type: -
Identifier Source: org_study_id
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