Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS)
研究概览
简要总结
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.
详细描述
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.
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
- Single (Participant)
盲法说明
Masking only Participant
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be considered eligible for enrolment into the study, subjects must:
- •Be able to give written informed consent.
- •Males and females aged >18 and <75
- •Have IBS as defined by the Rome IV criteria
排除标准
- •Subjects will be excluded from the study if they meet any of the below criteria:
- •pregnant or having a follow-up of less than 6 months;
- •unable to give informed consent;
- •suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
- •unable to undergo endoscopy.
研究组 & 干预措施
fecal microbiota transplantation
fecal microbiota transplantation
干预措施: fecal microbiota transplantation (Procedure)
placebo fecal microbiota transplantation
Infusion of sham
干预措施: Infusion of sham (Procedure)
Traditional treatments
Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants
干预措施: probiotics, antibiotics or antidepressants (Drug)
结局指标
主要结局
Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS)
时间窗: baseline; one month;three months;six months
This questionnaire was used for assessing IBS severity. Scores of five questions were calculated with the Visual Analogue Scale (VAS) scale: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits and interference with quality of life. The scores ranged from 0 to 500, a higher score indicating worse condition :\<75 indicated remission; 75-175 indicated mild IBS;176-300 indicated moderate IBS; and \> 300 indicated severe IBS .
次要结局
- Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA)(baseline; one month;three months;six months)
- Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores(baseline; one month;three months;six months)