Fecal Transplantation for Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Improvement of disease activity index.
研究概览
简要总结
Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The feces of a healthy individual is fluidized and than inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. There are reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small.
aim: To investigate whether use of FMT will bring improvement for colitis in IBD patients . Methods: The patients will undergo full colonoscopy, the stool preparation will be infused through the colonoscope during withdrawal of the instrument.
详细描述
Back ground: intestinal microbiota have a central role in disease pathogenesis, either in a form of a "permissive" role or as a direct pathogenic cause.
Clostridium difficile colitis; irritable bowel syndrome (IBS) and IBD have all been connected to a disturbance in the equilibrium of intestinal microbiome. But the causative mechanism is not yet known. (5-10) . Various bacteria including lactobacillus acidophilus and bifidobacterium bifidus are being empirically used as treatment for many intestinal ailments. The cause of inflammatory bowel disease in unknown but evidence is gathering that excessive immune reaction of intestinal immune system to microflora combined with a genetic predisposition are responsible for the chronic inflammation.
Fecal microbial treatment (FMT) is a treatment that utilizes the microbiota of a healthy intestine as a probiotic preparation. The feces of a healthy individual is fluidized and that inserted into the intestinal tract of a sick individual, assuming that the healthy flora will colonize and cure the intestine. Previous work had shown success in fecal transplantation as a treatment for clostridium difficile colitis. There are also reports of the efficacy of this treatment for inflammatory bowel disease but currently the numbers are small. A review by Anderson et al describes 17 studies reporting treatment of IBD by FMT. (12). In 9 cases it was done to treat IBD and in 8 cases for intestinal infection in IBD patients. Altogether 41 cases were reported , In some the FMT was inserted through a nasogastric tube directly to the duodenum, in some be colonoscopy and in some by an enema. A significant clinical improvement was reported in 19/25 patients. 13/17 stopped IBD treatment , 15/24 entered full clinical remission. In all 15 patients treated for infection the treatment was successful. No sever adverse effects were reported, Fever was developed in 8 cases and in one case there was exacerbation of colitis after treatment.
Primary aim: To investigate whether use of FMT will bring improvement of at least 2 points in partial mayo score in ulcerative colitis patients, or 70 points in CDAI of patients with Crohn's colitis. One month after FMT.
Improvement will be defined as:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Inflammatory bowel disease diagnosed at least 3 months ago
- •Failure of either one immunomodulator of at least 3 months duration, or TNF inhibitor full induction treatment, or intolerance to either of these drugs.
- •Currently active disease, partial Mayo score ≥4 for ulcerative colitis, or CDAI ≥200 for CD.
- •negative HIV , HTLV I/II, negative stool culture, Negative C diff toxin, negative CMV
排除标准
- •No informed consent
- •Non active inflammatory bowel disease.
- •Active infection in either the donor or the recipient,
结局指标
主要结局
Improvement of disease activity index.
时间窗: 4 weeks
: a decrease of at least 2 points in the partial mayo score, and a decrease of at least 1 point in endoscopic Mayo score. For Crohn's disease: A decrease of at least 70 points in CDAI.
次要结局
- Maintenance of remission/ improvement during follow up(6 months)
- Patients perspective of the treatment (do patients regard the treatment as acceptable)(6 months)
- Cost estimation of the treatment(6 months)
- improvement of endoscopic score(4 weeks)
- side effects (presence of fever,or rise of 50% or more in the number of bowel movements)(6 months)