FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CSBMs per week
研究概览
简要总结
Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. This trial is based on the theory of the gut-brain-microbiota axis. Patients with constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the potential role of gut microbiome in these gut-brain disorders.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ criteria were enrolled.
- •Age ≥ 18 years
- •Body mass index of 18-25 kg/m
- •HAMA ≥ 14 and/or HAMD (17 items) ≥ 17
排除标准
- •History of sever mental disorders such as schizophrenia and bipolar disorder
- •History of organic intestinal disorders
- •History of gastrointestinal surgery
- •Pregnant or breast-feeding women
- •Infection with enteric pathogen
- •Usage of probiotics, prebiotics, antibiotics within the last month
- •Uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in the opinion of the investigator, could affect intestinal transit and the intestinal microbiota.
- •Patients who could not complete the follow-up
研究组 & 干预措施
FMT group
干预措施: FMT (Other)
结局指标
主要结局
CSBMs per week
时间窗: 12 weeks after treatment
complete spontaneous bowl movements per week
HAMA
时间窗: 12 weeks after treatment
score of Hamilton Anxiety Rating Scale
HAMD
时间窗: 12 weeks after treatment
score of Hamilton Depression Rating Scale
次要结局
- Bristol Bristol PAC-SYM(pre, 2 weeks, 4 weeks, 8 weeks, 12weeks)
- PAC-QOL(pre, 2 weeks, 4 weeks, 8 weeks, 12weeks)
- Wexner(pre, 2 weeks, 4 weeks, 8 weeks, 12weeks)
- PAC-SYM(pre, 2 weeks, 4 weeks, 8 weeks, 12weeks)
研究者
Jianfeng Gong
Professor, Associate senior doctor
Jinling Hospital, China