Study of the Effects of Fecal Microbiota Transplantation for Correction of the Physiological State of the Human Body in Norm and in Pathology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Ulcerative Colitis remission
研究概览
简要总结
Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.
详细描述
Objectives of the study:
- To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms.
- To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control.
- Create a bank of fecal samples of healthy donors;
- Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers;
- Analyze the efficacy of therapy with TFM on the sample of patients;
- Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers;
- Analyze long-term effects in patients within 6 months after the TPM.
The study is expected to include 50 patients, 35 healthy volunteers and healthy feces donors The study is scheduled to begin in May 2018, the supposed completion of the study is December 2020
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •the age of patients - from 18 to 75 years, both sexes;
- •Patients with:
- •antibiotic-associated colitis,
- •inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
- •diseases caused by C. difficile infection,
- •a syndrome of impaired intestinal absorption,
- •irritable bowel syndrome,
- •celiac disease (severe form),
- •metabolic syndrome, including diabetes mellitus type II,
- •Atopic dermatitis with damage to the mucous membrane of the colon,
- •hepatitis of various etiologies,
- •cirrhosis of the liver of various etiologies
- •pancreatitis of various etiologies,
- •Absence of contraindications to gastroscopy
- •informed consent of the patient for the transplant procedure
排除标准
- •the presence of a concomitant chronic infectious or neoplastic disease in the patient
- •Patients with a proven allergy to foods not excluded from the donor's diet
- •absence of the patient for one or more intermediate stages of the examination.
- •informed refusal to continue therapy
研究组 & 干预措施
Participants with bowel diseases
Treatment by transplantation of fecal microbiota
干预措施: Fecal Microbiota Transplantation (Other)
autologous transplantation of fecal microbiota - healthy
Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules)
干预措施: Fecal Microbiota Transplantation (Other)
Both autologous and heterologous transplantation - healthy
Healthy volunteers will receive both autologous and heterologous transplantation (capsules)
干预措施: Fecal Microbiota Transplantation (Other)
placebo capsules - healthy
Healthy volunteers will receive placebo capsules
干预措施: Fecal Microbiota Transplantation (Other)
结局指标
主要结局
Ulcerative Colitis remission
时间窗: 1 month after transplantation. Change from Baseline - 1 day before transplantation
Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index \<3
Crohn Disease remission
时间窗: 1 month after transplantation. Change from Baseline - 1 day before transplantation.
Crohn Disease remission defined as a Harvey-bradshaw index \<3.
次要结局
- Change in gut microbiome(1 month after transplantation. Change from Baseline - 1 day before transplantation.)
- Improvement in Ulcerative Colitis symptoms.(1 month after transplantation. Change from Baseline - 1 day before transplantation.)