Clinical trial NCT03526796: Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis
Official title: Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pouchitis
Hyperbaric Oxygen Therapy
Keywords: Pouchitis
Hyperbaric oxygen therapy
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Remission rate
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Response rate
timeFrame: up to 4 weeks
measure: Symptomatic improvement rate
timeFrame: up to 4 weeks
measure: Endoscopic improvement rate
timeFrame: up to 4 weeks
measure: Fecal calprotectin level
timeFrame: up to 4 weeks
measure: Plasma C-reactive protein level
timeFrame: up to 4 weeks
measure: Plasma Interleukin-6 level
timeFrame: up to 4 weeks
measure: Fecal microbiome
timeFrame: up to 4 weeks
measure: Adverse events
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Jianfeng Gong, MD
role: PRINCIPAL_INVESTIGATOR
References: