Hyperbaric Oxygen Therapy, Pouchitis
Conditions
Keywords
Pouchitis, Hyperbaric oxygen therapy
Brief summary
The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.
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).
Interventions
PROCEDUREHyperbaric 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.
Sponsors
Jinling Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate | up to 4 weeks | Defined by a pouchitis disease activity index (PDAI) score of \< 7 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic improvement rate | up to 4 weeks | Reduction of PDAI clinical subscore \>2 points. |
| Endoscopic improvement rate | up to 4 weeks | Reduction of PDAI endoscopic subscore \>2 points. |
| Fecal calprotectin level | up to 4 weeks | Fecal caprotectin level before and after treatment |
| Response rate | up to 4 weeks | Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system |
| Plasma Interleukin-6 level | up to 4 weeks | Plasma Interleukin-6 level before and after treatment |
| Fecal microbiome | up to 4 weeks | Fecal microbiome analysis using 16S RNA technique before and after treatment |
| Adverse events | up to 4 weeks | Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment. |
| Plasma C-reactive protein level | up to 4 weeks | Plasma caprotectin level before and after treatment |
Countries
China
Contacts
Primary ContactJianfeng Gong, MD
Outcome results
None listed