Efficacy and Safety Evaluation of Rifaximin Combined Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of patients with relief of IBS condition
研究概览
简要总结
The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.
详细描述
In this prospective study, there is only one group with no placebo/blank control. All qualified IBS-D patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age between 18 and 65, no gender limitation;
- •Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed;
- •Has current symptoms of IBS-D: ①Abdominal pain (at least 2 days in a week with no limitation of severity); ②Stool consistency (rated the consistency of their stools of Bristol types 6/7 at least once a day and at least 2 days in a week);
- •Can do follow-up at required time points and signed written informed consent before the study.
排除标准
- •Allergic to rifaximin;
- •Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month;
- •Had infective diarrhea history or had taken antibiotics within the previous 14 days;
- •Patients with a history of inflammatory bowel disease ;
- •Previous abdominal surgery (other than cholecystectomy or appendectomy);
- •Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs;
- •Unstable diabetes, hypertension, thyroid disease, etc;
- •Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases;
- •Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc;
- •Other conditions that doctor thought not suitable for the study.
研究组 & 干预措施
Combining therapy
taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
干预措施: Rifaximin (Drug)
Combining therapy
taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube
干预措施: Fecal microbiota transplantation (Procedure)
结局指标
主要结局
Number of patients with relief of IBS condition
时间窗: 6 months after the treatment
The "responder" should at the same time get relief of at least one item of abdominal discomfort related symptoms(including abdominal pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain) and bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), both items' effectiveness are defined as decreasing at least 30% compared with baseline) and at least one item of defecation related abnomalities(including average daily defecation(effectiveness defined as decreasing at least 30% compared with baseline) and stool consistency(effectiveness defined as feces could reach at least Bristol type 5) ).
次要结局
- Number of patients with relief of IBS related anxiety or depression status(1 month/2 month/3 month/6 month after the treatment)
- Number of patients with relief of IBS single symptoms(2 week/1 month/2 month/3 month/6 month after the treatment)