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临床试验/NCT02201186
NCT02201186已完成2 期

To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis (Pilot Study)

Dr. Carl J Brown2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
PDAI score

研究概览

简要总结

Patients with a bowel condition called ulcerative colitis have bowel surgery in which a portion of their bowel is removed and the reconnected at the small bowel to the anus. Sometimes, after the surgery, this connection part, the pouch, would be inflamed in a condition called Acute Pouchitis. Physicians usually treat them by prescribing antibiotics; however, some patients do not respond and need additional surgery. In this study, we will test an alternative treatment for this complication by performing manuka honey enemas twice a day for 30 days. This is a pilot study and ten patients will undergo enema treatment.

详细描述

Pouchitis is the most common long-term complication of ileal pouch-anal anastomosis (IPAA) in ulcerative colitis (UC). Pouchitis is defined as a clinical syndrome of watery, frequent, at times bloody stool accompanied by urgency, incontinence, abdominal cramps, malaise, and fever. The PDAI (Pouchitis Disease Activity Index) provides a standardized definition of pouchitis based on clinical, endoscopic, and histological markers. Pouchitis is defined as a score ≥ 7 and remission as a score < 7. Recently, the modified Pouchitis Disease Activity Index has been used to omit biopsy and histology from the standard PDAI. Omission of endoscopic biopsy and histology from the PDAI simplifies pouchitis diagnostic criteria, reduces the cost of diagnosis, and avoids delay associated with determining histology score, while providing equivalent sensitivity and specificity. Patients with acute pouchitis are managed routinely by antibiotics such as Ciprofloxacin and Metronidazole. This treatment has some side effects, is expensive, and fails to respond in some patients. Some patients who are unresponsive to antibiotic therapy will need to have a pouchectomy and ileostomy done.

On the other hand, multiple studies have shown that honey, especially manuka honey has anti-inflammatory, anti-bacterial, wound healing, and anti-ulcerous effects. Phenolic compounds in honey, such as flavonoids, have been reported to exhibit a wide range of biological activities, including antibacterial, antiviral, anti-inflammatory, antioxidant, antitumor, anti-allergic, and vasodilatory actions. This honey can clear infection, remove malodour, reduce inflammation and pain, cause edema and exudation to subside, and increase the rate of healing by stimulation of angiogenesis, granulation and epithelialization.

Due to problems associated with antibiotic therapy, such as side effects, cost and failure of some patients to respond, we are looking to find an alternative method for treating acute pouchitis. This study is designed to determine the effect of manuka honey on symptoms, signs and pathology of acute pouchitis patients. We will select patients with any of the signs and symptoms of pouchitis, such as abdominal pain, fever, frequency or urgency of defecation. Proctoscopy will be done before and after honey enema and the modified PDAI scores will be determined. The manuka honey enema will be administered twice a day, for one month. Then, the modified PDAI scores before and after completion of honey enema treatment of these patients, will be compared.

We know that bacterial overgrowth, ischemia, faecal stasis, recurrence of ulcerative colitis in the pouch, or possibly a novel third form of inflammatory bowel disease, are possible etiologies of pouchitis. We also know that manuka honey has anti-inflammatory and anti-bacterial properties. Some studies demonstrate that honey is effective in the treatment of induced colitis in animal models. However, there is no current literature on the effect of honey on colitis or pouchitis in humans. Based on the aforementioned properties of honey, and considering the probable etiologies of pouchitis, we expect that these patients will respond to this method of treatment.

Some research has been done on the effect of honey in the treatment of colitis in animal models, but there have been no clinical studies that have assessed this treatment in pouchitis, or even colitis, in humans. Considering the etiologies of pouchitis, such as inflammation and bacterial overgrowth, and considering the main effects of honey, such as anti-bacterial and anti-inflammatory efficacy, honey enema may be useful in the treatment of pouchitis. Our study is trying to determine the effect of manuka honey enema in the treatment of acute pouchitis. We will try to determine whether the honey enema helps to decrease inflammation and infection in the pouch, and thereby provide us with a safe alternative method for the treatment of 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
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have given written informed consent
  • have been diagnosed with ulcerative colitis
  • have had total colectomy and ileal pouch anal anastomosis before
  • have presented with signs and symptoms of pouchitis within the last two months of signing the informed consent
  • PDAI of greater than or equal to 7

排除标准

  • patients who are unable to perform enema by themselves
  • patients with an allergy to honey

结局指标

主要结局

PDAI score

时间窗: within 2 weeks after the 30-day treatment

PDAI score is a criterion for defining pouchitis. A PDAI score will be calculated from a proctoscopy assessment before treatment. Within two weeks after the treatment, another proctoscopy will be performed to determine the post-treatment PDAI score to see if there is a decrease in PDAI score for the study patients.

次要结局

  • Composite complications(throughout the 30-day honey enema treatment and within two weeks of the treatment completion date)

研究者

发起方
Dr. Carl J Brown
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Carl J Brown

Head, Division of General Surgery, clinical assistant professor of surgery at University of British Columbia

St. Paul's Hospital, Canada

研究点 (2)

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