Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis

Study Overview
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Brief Summary
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The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.

Detailed Description
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Pouch ischemia plays an important role in the pathogenesis of pouchitis after IPAA surgery for ulcerative colitis. Obese Male patients are at high risk for pouchitis because of mesenteric tension. Excessive weight gain is associated with an increased risk for pouch failure in patients with restorative proctocolectomy. Also, patients with an 'S' pouch hardly ever develop chronic pouchitis, owing to the additional length of bowel loop along with mesentery when attached to the anal transitional zone. The treatment of chronic antibiotic-refractory pouchitis(CARP) is difficult. 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).

Official Title
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Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial

Conditions
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Pouchitis, Hyperbaric Oxygen Therapy

Intervention / Treatment
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* Procedure: Hyperbaric oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IPAA performed for ulcerative colitis; 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: Crohn's disease of the pouch 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy<br>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. | Procedure: Hyperbaric oxygen therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate | Defined by a pouchitis disease activity index (PDAI) score of < 7 points | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system | up to 4 weeks | 
| Symptomatic improvement rate | Reduction of PDAI clinical subscore >2 points. | up to 4 weeks | 
| Endoscopic improvement rate | Reduction of PDAI endoscopic subscore >2 points. | up to 4 weeks | 
| Fecal calprotectin level | Fecal caprotectin level before and after treatment | up to 4 weeks | 
| Plasma C-reactive protein level | Plasma caprotectin level before and after treatment | up to 4 weeks | 
| Plasma Interleukin-6 level | Plasma Interleukin-6 level before and after treatment | up to 4 weeks | 
| Fecal microbiome | Fecal microbiome analysis using 16S RNA technique before and after treatment | up to 4 weeks | 
| Adverse events | Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment. | up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pouchitis, Hyperbaric oxygen therapy