Fecal Microbiota Transplantation in Patients With Post-infection Irritable Bowel Syndrome: a Randomized, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in Irritable bowel syndrome severity scoring system (IBS-SSS)
研究概览
简要总结
Considering that PI-IBS is brought on by infection and gut microbiota may be associated with the onset of symptoms, the modification of altered gut microbiota with nonabsorbable antibiotics such as rifaximin-α or probiotics is often employed as first-stage treatment. Research in recent years has also shown the potential benefits of fecal microbiota transplantation (FMT) for IBS, which is the replacement of a sick recipient's gut microbiota with fecal material from a healthy donor. Even though the only officially approved indication for FMT at this time is recurrent Clostridium difficile infection, the effectiveness of FMT is nevertheless being studied for the treatment of other gastrointestinal and non-gastrointestinal pathologies including IBS. To date, several controlled and uncontrolled studies have been conducted to study the effectiveness of FMT for IBS, and most of them have demonstrated positive results. The investigators have not come across studies devoted to the study of the effectiveness of FMT in patients with PI-IBS in the available literature. So, the aim of the current study was to conduct single-centre, randomized clinical trial to assess the safety, clinical and microbiological efficacy of FMT in patients with PI-IBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •systemic disease, immunodeficiency, or previous treatment with immunomodulators;
- •pregnant or breastfeeding;
- •previous surgery on the abdominal cavity, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- •severe current disease (hepatic, renal, respiratory, or cardiovascular);
- •probiotic or antibiotic use within 8 weeks prior to study initiation;
- •any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results.
研究组 & 干预措施
Fecal transplantation group
Fecal transplantation of frozen prepared feces from healthy donor. Application by colonoscope in proximal half of colon.
干预措施: Fecal transplantation (Biological)
Standard-care group
FODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID)
干预措施: OTILONII BROMIDUM (Drug)
Standard-care group
FODMAP diet, Otilonium Bromide, oral, (40mg, 1 tablet TID) and a multi-strain probiotic, oral, (1 capsule BID)
干预措施: multi-strain probiotic (Dietary Supplement)
结局指标
主要结局
Change in Irritable bowel syndrome severity scoring system (IBS-SSS)
时间窗: at 0, 2, 4 and 12 weeks
This questionnaire contains five questions, each with a maximum score of 100 using a visual analog scale. Total scores between 75 and 175 were considered indicative of mild IBS severity, 175-300 were moderate, and \>300 were severe.
assesment of response rate
时间窗: at 12 weeks
response rate was assessed as decrease of ≥ 50 points on the IBS-SSS
次要结局
- Change in BS Quality of Life Scale (IBS-QoL)(at 0, 2, 4 and 12 weeks)
- Bacteriology measured in the stool flora by specialized non-culture techniques(at 0 and 1 months)
- Microbiome profile change(at 0 and 1 months)
- Change in Fatigue Assessment Scale (FAS)(at 0, 2, 4 and 12 weeks)
研究者
Nazarii Kobyliak
Associate Professor, Endocrinology Department
Bogomolets National Medical University