Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Hyperbaric oxygen therapy (Procedure)
结局指标
主要结局
Remission rate
时间窗: up to 4 weeks
Defined by a pouchitis disease activity index (PDAI) score of \< 7 points
次要结局
- Response rate(up to 4 weeks)
- Symptomatic improvement rate(up to 4 weeks)
- Endoscopic improvement rate(up to 4 weeks)
- Fecal calprotectin level(up to 4 weeks)
- Plasma C-reactive protein level(up to 4 weeks)
- Plasma Interleukin-6 level(up to 4 weeks)
- Fecal microbiome(up to 4 weeks)
- Adverse events(up to 4 weeks)
研究者
Jianfeng Gong
Associate Professor
Jinling Hospital, China