Efficacy and Safety of Fecal Microbiota Transplantation in Radiation Enteritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
Radiation enteritis is one of the most feared complications after abdominal or pelvic radiation therapy.The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body metabolism. Evidence from animal studies demonstrated the link between intestinal bacteria and radiation enteritis. This clinical trial aims to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) for radiation enteritis.
详细描述
The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through fecal microbiota transplantation (FMT) for radiation enteritis (RE). FMT is the whole profile of fecal microbiota transplantation. At enrollment, "Shared Decision Making" intervention was applied to support patient involvement in making health decisions. Patients have opportunity to choose fecal microbiota transplantation (FMT). Patients will receive follow-up for at least 12 weeks. Blood test, endoscopy and questionnaire will be used to access participants at study start and at study completion. Fecal microbiota compositions, blood and urinary metabolic profiles of patients will be analyzed to assess associated microbial changes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years old;
- •Radiation enteritis diagnosed by colonoscopy after finishing radiotherapy.
排除标准
- •Patients who were pregnant or nursing;
- •Patients who were unable or unwilling to undergo a gastroscopy;
- •Patients who had gastrointestinal infection;
- •Patients with cardiopulmonary failure.
研究组 & 干预措施
Basic treatment
Patient receives basic therapy for RE during hospitalization
Fecal Microbiota Transplantation (FMT)
Patients receive a course of FMT during hospitalization
干预措施: Fecal Microbiota Transplantation (FMT) (Procedure)
结局指标
主要结局
Clinical response rate
时间窗: 12 weeks
The clinical response rate at 8 weeks after fmt treatment
次要结局
- Scores of gastrointestinal symptoms(4, 8, 12 weeks)
- Change of toxicity grade(4, 8, 12 weeks)
研究者
Faming Zhang
Professor, Microbiota Medicine, Gastroenterology
The Second Hospital of Nanjing Medical University