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临床试验/NCT03538366
NCT03538366已完成不适用

Fecal Microbiota Transplantation for the Treatment of Chronic Pouchitis

Aalborg University Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Cure 30 days following FMT treatment

研究概览

简要总结

Patients with chronic pouchitis are treated with fecal transplant from several unrelated, healthy donors. The treatment consists of enemas of 100 mL fecal suspension, applied for 14 consecutive days.

详细描述

Background:

The surgical treatment of choice for the treatment of medically refractory ulcerative colitis (UC) is restorative ileal pouch-anal anastomosis (IPAA), in which the patient retains fecal continence following colonectomy, by subsequent anastomosis of the terminal ileum and the rectum.

Up to 25% of patients with UC will undergo IPAA surgery. The most common complication following the procedure is inflammation of the pouch (pouchitis), which is seen in up to 50% of patients within the first five years of surgery. Of these patients, 10-20% will develop a chronic inflammatory condition. The clinical symptoms of pouchitis include diarrhea, rectal bleeding, stomach cramps, general malaise and reduced quality of life. Endoscopic findings include mucosal edema, granulations, and ulcerations with mucosal frailty. In most cases, a causative microorganism is not identified, although infection with Clostridium difficile or Cytomegalovirus (CMV) have been reported.

The most common treatment of pouchitis is empiric antibiotics, usually quinolones and metronidazole, or a combination of both. Following complications, removal of the pouch can become a last resort, and chronic pouchitis is the leading indication for 10% of these operations.

The composition of microbes in the gut is known to be a key factor in the homeostasis of the intestine, and plays a central role in the development of CIBD. Different single microorganisms have previously been suggested as playing an important role in this development, including: Mycobacterium avium, Escherichia coli and Clostridium difficile, that all have invasive capabilities. Several studies have investigated the connection between the composition of microbes in the gut and development of pouchitis finding an increasing evidence for a link between dysbiosis and pouchitis.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • minimum 18 years old, pouch > 1 year
  • at least three pouchitis events in the past year
  • antibiotic treatment for pouchitis at least one time in the past year

排除标准

  • immunosuppression, pregnancy, detection of specific pathogens in stool

结局指标

主要结局

Cure 30 days following FMT treatment

时间窗: 30 days

PDAI \< 7

次要结局

  • Histological remission following PDAI(30 days)
  • Improvement of pouch function(30 days)
  • Changes of the microbiota(30 days)
  • Clinical response 30 days after FMT treatment(30 days)
  • Improvement of quality of life(30 days)
  • Improvement of sexuality(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

MD, DMSc, Professor of Surgery

Aalborg University Hospital

研究点 (2)

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