Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stool frequency and consistency
研究概览
简要总结
Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •solid organ transplantation recipients;
- •suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;
- •is willing to undergo WMT and provide written informed consent;
排除标准
- •patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
- •pregnant or lactating females;
- •unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
- •follow up less than 1-month post-WMT;
- •other conditions judged by investigators not suitable for study participation;
结局指标
主要结局
Stool frequency and consistency
时间窗: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Stool frequency and consistency will be evaluated according to the Bristol Stool Form Scale (BSFS, ranging from type 1 - type 7)
Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
Pathogen detection and culture
时间窗: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Pathogen was detected and cultured from serum, urine, stool and so on before and after WMT.
次要结局
- Adverse events(AEs)(Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT)
- Gut microbiota(Baseline, 3-month post WMT)
- Quality of life by SF-36(Baseline, 3-month post WMT)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University