Faecal Microbiota Transplantation (FMT) in Patients With Irritable Bowel Syndrome (IBS): Optimizing the Treatment and Its Mechanism(s) of Action
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Change in IBS-SSS total score
研究概览
简要总结
Two hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine via working channel of a gastroscope, or to 90 g transplant into the coecum of the colon via working channel of a colonoscope. The patients shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial are determined by using 16S rRNA gene.
详细描述
Patients Two hundrad patients who fulfil Rome IV criteria for irritable bowel syndrome (IBS) shall be included in the study. All the IBS subtypes shall be included.
Donor Investigators are going to use the same super-donor they used in their previous randomised double-blind, placebo-controlled study. The donor is athletic Caucasian man aging 36 years. He is non-smoker and is completely healthy without any medication and with a BMI of 23.5. He is not relative to any of the patients in the trial. He was borne by vaginal delivery and breastfeed. He was treated 3 times with antibiotics during his life. He trains 5 times weekly an hour each time. He took regularly dietary supplements rich in proteins, vitamins, fibres and minerals that made his diet richer than average in these substances. He was screened according to the guidelines for donors for FMT. Before he was accepted as a donor the microbiota was analysed in a faecal sample using GA-map Dysbiosis test. The analysis revealed a dysbiosis index (DI)= 1, indicating normobiosysis. In addition, he had excess of bacteria belonging to the Firmicutes. His faeces shall be tested every third moth during the trial.
Protocol
The patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine, or to 90 g transplant into the coecum of the colon. The patients shall complete 5 questionnaires and deliver fecal samples at the baseline, and at 3 , 6 , and 12 months after FMT.
Faeces collection, preparation and administration Faeces from both the donor and patients shall be collected and stored at - 80•. Frozen faeces shall be thawed and each 30 g is dissolved in 30 mL of 0.9% sterile saline. The dissolved stool administrated to the patients, after overnight fast, through working channel of gastroduodeno-scope in pars descendent duodenum distal to the papilla of Vater or to the coecum through working channel of a colonoscope.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfil Rome IV criteria for the diagnosis of IBS.
- •Patients were investigated to exclude other gastrointestinal organic cause(s).
- •Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS).
排除标准
- •Pregnant or lactating women.
- •The use of antibiotics or probiotics within 1 month prior to FMT.
- •Immunocompromised patients defined as those treated by immune- suppressive medications.
- •Patients with co-morbidity such as kidney failure or chronic heart disease.
- •System disease such as diabetes.
- •Patients with serious psychiatric disorders or drug abuse.
结局指标
主要结局
Change in IBS-SSS total score
时间窗: 12 months after FMT
Irritable bowel syndrome-symptom severity score (IBS-SSS) is a visual analogue scale questionnaire with a maximum score of 500 points. A decrease in total score by ≥50 points is considered as a response.
次要结局
- Change in the Dysbiosis index(12 months after FMT)