Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis
NCT ID: NCT03526796
Last Updated: 2018-05-16
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-06-01
2020-07-31
Brief Summary
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Detailed Description
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Hyperbaric oxygen therapy(HBOT) have been proven effecitve in the treatment of inflammatory bowel diseases(IBD). Meta-analysis revealed that the overall response rate was 86% (85% CD, 88% UC), and of the endoscopic response rate to HBOT is 100%. The possible mechanism might be due to the prmoted wound healing by increasing oxygen delivery to hypooxic tissues and changes in inflammatory and immunological mediators.
Therefore, the aim of current study is to examine the therapeutic effect of HBOT for chronic antibiotic-refractory pouchitis(CARP).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hyperbaric oxygen therapy
Patients who recieve hyperbaric oxygen therapy will be maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Hyperbaric oxygen therapy
Patients were maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Interventions
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Hyperbaric oxygen therapy
Patients were maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Eligibility Criteria
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Inclusion Criteria
* Pouchitis Disease Activity Index (PDAI) scores ≥7;
* Antibiotic refractory pouchitis(CARP), defined as patients who do not respond to conventional 2-week, single-agent antibiotic therapy including metronidazole,ornidazole,tinidazole, or ciprofloxacin
* 18-75years
* Informed consent given
* Able and willing to comply with all trial procedures
* Including prepouch ileitis
Exclusion Criteria
* Pouchitis after IPAA for FAP
* Isolated cuffitis
* with cocomttant Primary sclerosing cholangitis (PSC)
* Pouch strictures
* Abscess/Sinuses
* Perianal disease
* Active malignancy
* Uncontrolled systemic diseases
* History of noninfammatory disease of the pouch
* Decreased pouch compliance
* Irritable pouch syndrome
* Afferent or efferent limb obstruction
* Needing oral or topical steroid or 5-ASA
* Major physical or psychiatric illness within the last 6m
* Active use of cholestyramine, NSAIDs or aspirin
* Pregnant, breast feeding
* Clinically significant co-morbidities causing untolerant or unsuitable for hyperbaric oxygen therapy.
18 Years
75 Years
ALL
No
Sponsors
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Jinling Hospital, China
OTHER
Responsible Party
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Jianfeng Gong
Associate Professor
Principal Investigators
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Jianfeng Gong, MD
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, China
Locations
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Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Other Identifiers
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HBOT-pouchitis
Identifier Type: -
Identifier Source: org_study_id
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