Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of adverse events complication rate in all patients in both groups
研究概览
简要总结
Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease，but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.
详细描述
Patients who meet the inclusion crit chronic functional constipation will be separated into two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal motility.
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
- 是
入选标准
- •subjects voluntarily participate in the trial and sign informed consent;
- •sex is not limited,ranging from 18 to 75 years old;
- •meet the diagnostic criteria for chronic functional constipation in patients;
- •patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month;
- •be able to communicate well with the researchers and follow the verification requirements.
排除标准
- •does not meet the diagnostic criteria;
- •with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases;
- •severe anemia and severe systemic infection;
- •suspected or indeed have alcohol, drug abuse history;
- •pregnancy or are preparing for pregnancy, and breastfeeding women;
- •Those who are unwilling to accept the research measures or other reasons can not cooperate;
- •due to mental disorders can not give adequate informed consent;
- •Participated in other clinical trials within 3 months before the start of the study;
- •researchers believe that participates are not suitable for other reasons in this clinical trial.
结局指标
主要结局
Number of adverse events complication rate in all patients in both groups
时间窗: 3 months
次要结局
- Microbiota composition(4 weeks)
- Nitric oxide(NO)(4 weeks)
- Mean number of bowel movements per week(4 weeks)
- Bristol stool scale(4 weeks)
- Constipation-related symptoms assessments(4 weeks)
- Usage of laxatives or enemas as rescue medication(4 weeks)
- Histological changes in the intestinal biopsy in both groups.(4 weeks)