NCT04637438招募中不适用
Fecal Microbiota Transplantation in Postoperative Crohn's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in endoscopic Rutgeerts score between first and second colonoscopy
研究概览
简要总结
This pilot study aims to detect possible trends or signals suggesting efficacy of FMT on prevention of delay of POR, to determine the safety of FMT in post operative CD, and asses if a full randomised controlled trial is feasible in this setting. With microbiota analysis we aim to assess if changes in gut microbiota are related to disease course of CD after operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years
- •Able to provide written consent
- •Stricturing and/or fistulizing Crohn's disease needing ileocecal or ileal resection
排除标准
- •Pregnancy
- •Active infection, abscess or fistula at the time of the first colonoscopy
- •Life expectancy <1 year
- •Unable to provide written consent
- •Use on antibiotics or probiotics at the time of first colonoscopy
结局指标
主要结局
Change in endoscopic Rutgeerts score between first and second colonoscopy
时间窗: 1 year
Rutgeerts endoscopic score ranges from i0 indicating remission to i4 indicating severe post-operative relapse. Cut off value \> i1 will be used to compare number on patients in intervention group and in placebo group.
次要结局
- Need for hospitalization(Through study completion, an avarage of 1 year and 5 years)
- Clinical activity of Crohn's disease using Harwey-Bradshaw Index(6 months, 12 months, 5 years)
- Histologic activity of Crohn's Disease using modified Global Histological Activity Score(1 years, 5 years)
- Change in inflammatory marker CRP mg/l(6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years)
- Need for treatment escalation(Through study completion, an avarage of 1 year and 5 years)
- F-calpro microg/g(6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years)
- Hb mg/l(6 weeks,12 weeks, 24 weeks, 48 weeks, 5 years)
- Safety of FMT using FinFMT-Questionnaire(3 months, 12 months, 5 years)
- Change of microbiota in stool samples and in intestinal biopsies(6 weeks,12 weeks, 48 weeks, 5 years)
- Patient reported outcome(12 weeks, 48 weeks,years 5)
研究者
Elina Jokinen
Doctor of Medical Science
Tampere University Hospital
研究点 (2)
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