The Role of Fecal Microbiota Transplantation for maintenance of remission in patients with ulcerative colitis
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comparison of clinical response in two groups
研究概览
简要总结
The role of gut microbiome in health and inflammation has gained international attention in recent times. The success of fecal microbiota transplantation (FMT) (a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with the goal being to introduce or restore a stable microbial community in the gut) in treatment of Clostridium difficile infection led to the hypothesis that it may play an important role in Inflammatory Bowel Disease (IBD) as well. Randomized controlled trials have demonstrated efficacy of FMT in induction of remission in mild-moderate Ulcerative Colitis (UC). However there is paucity of data which looks into the role of FMT in maintenance of remission in Ulcerative Colitis. This study aims to study the role of fecal microbiota transplantation in maintenance of remission in UC. Patients will receive retention enemas or through colonoscopy and will be looked for remission/response at 6 months and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed Ulcerative Colitis patients who are in clinical remission (defined as complete resolution of symptoms) for a minimum duration of 6 months.
- •Patients must be on stable medication regimen for at least 6 months prior to enrollment.
- •Able to give informed consent and/or assent as appropriate.
排除标准
- •Patients with active disease
- •Patients having toxic megacolon
- •Treatment naïve patients
- •Pregnant and lactating ladies
- •Prior colectomy
- •Positive stool test for any of the following: Clostridium difficile, Salmonella, Shigella, Yersinia, Campylobacter, E.
- •coli by standard stool culture.
- •Regular probiotic supplement use within prior 4 weeks to enrollment
- •Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
- •Patients unwilling or unable to give consent or participate in all study requirements.
结局指标
主要结局
Comparison of clinical response in two groups
时间窗: One Year
次要结局
- Comparison of Endoscopic activity of Ulcerative Colitis(1 year)