Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis (HBOT-pouch)
Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210000
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Remission rate
Time Frame: up to 4 weeks
|
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
Time Frame: up to 4 weeks
|
Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
|
up to 4 weeks
|
|
Symptomatic improvement rate
Time Frame: up to 4 weeks
|
Reduction of PDAI clinical subscore >2 points.
|
up to 4 weeks
|
|
Endoscopic improvement rate
Time Frame: up to 4 weeks
|
Reduction of PDAI endoscopic subscore >2 points.
|
up to 4 weeks
|
|
Fecal calprotectin level
Time Frame: up to 4 weeks
|
Fecal caprotectin level before and after treatment
|
up to 4 weeks
|
|
Plasma C-reactive protein level
Time Frame: up to 4 weeks
|
Plasma caprotectin level before and after treatment
|
up to 4 weeks
|
|
Plasma Interleukin-6 level
Time Frame: up to 4 weeks
|
Plasma Interleukin-6 level before and after treatment
|
up to 4 weeks
|
|
Fecal microbiome
Time Frame: up to 4 weeks
|
Fecal microbiome analysis using 16S RNA technique before and after treatment
|
up to 4 weeks
|
|
Adverse events
Time Frame: up to 4 weeks
|
Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.
|
up to 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBOT-pouchitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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