ACTRN12614000503628已完成未知
Single centre, proof-of-concept, exploratory, parallel, controlled study using high-throughput DNA sequencing techniques to compare differences in the gastrointestinal (GI) microflora of Clostridium difficile infection (CDI) and ulcerative colitis (UC) patients before and after faecal microbiota transplantation (FMT)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •6 months or greater history of active moderate ulcerative colitis (Mayo score of 4-10) or diarrhoea (greater than 3 motions per day) in association with a confirmed diagnosis of Clostridium difficile infection (toxin positive).
- •Never had FMT treatment for any reason.
排除标准
- •Females who are pregnant or lactating.
- •Unwilling to practice an effective method of contraception throughout the study period.
- •Unwilling to use a sodium picosulfate-based bowel preparation.
- •Severe anemia, leucopenia or granulocytopenia.
- •Detection of a gastrointestinal pathogen on stool analysis, with the exception of Clostridium difficile for the Clostridium difficile infection group only.
- •Participants with Crohn’s disease, indeterminate colitis or isolated proctitis <5 cm.
- •Constipation-predominant ulcerative colitis with <2 bowel motions/day.
- •Evidence or history of toxic megacolon.
- •Any other significant gastrointestinal conditions e.g. neoplasms, irritable bowel syndrome.
- •Participants who have had a colectomy, bowel resection or other major gastrointestinal surgery.
研究者
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