FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- IBS symptom relieve
研究概览
简要总结
52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.
详细描述
52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization was done by personnel not treating the patient. The participant or FMT providing personnel did not know the result of randomization. The doctors assessing the outcome have been blinded of the result of randomization.
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
- •Diagnosis of IBS based on Rome III criteria
- •Having received traditional treatment for at least 1 month
- •Availability of consecutive fecal samples over one year.
- •Compliance to attend ileocolonoscopy and FMT procedure.
- •18-75 years
排除标准
- •Unable to provide informed consent
- •Antibiotic therapy in past 3 months
- •Inflammatory bowel disease (IBD)
研究组 & 干预措施
FMT
IBS patients randomized to receive FMT from a healthy donor.
干预措施: Fecal Microbiota Transplantation (FMT) (Other)
Placebo
IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo.
干预措施: Placebo (Other)
结局指标
主要结局
IBS symptom relieve
时间窗: 52 weeks
Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and \> 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.)
次要结局
未报告次要终点