A Prospective, Single-Arm Trial of Fecal Microbiota Transplantation for Hemorrhagic Radiation-Induced Rectal Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with mild rectal bleeding (grade 0-1)
研究概览
简要总结
The goal of this single-arm trial is to learn if Fecal Microbiota Transplantation (FMT) works to treat hemorrhagic radiation-induced proctopathy. The main questions it aims to answer are:
- Dose FMT alleviate the symptom of severe rectal bleeding?
- Dose FMT improve the endoscopic findings of proctopathy?
Participants will:
- Take fecal microbiota capsules by 8 sessions over a 12-week period.
- Visit the clinic once every 4 weeks for checkups and tests.
- Keep a diary of their symptoms and the number of times they use other supportive care.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old
- •At least 3 months since the completion of pelvic radiotherapy
- •No evidence of tumor recurrence or metastasis
- •Rectal bleeding with grade 2-4 by LENT-SOMA scales
- •Colonoscopy indicating rectal congested mucosa or telangiectasia
- •Poor response to supportive care, or hemoglobin level less than or equal to 70 g/L in the past 3 months
排除标准
- •Acute or chronic infectious diseases
- •Serious systemic diseases
- •Known allergies to any components of the study medication
- •Colonoscopy indicating rectal ulceration (>1cm2), fistula, stricture, or necrosis
- •Late complications related to pelvic radiation injury
- •Other hemorrhagic or coagulation disorders
- •Previous rectal resection
- •Bowel obstruction or perforation that require surgery
- •Cognitive or psychological disorder
- •Contraindications to FMT administration
研究组 & 干预措施
Fecal Microbiota Transplantation
Fecal microbiota capsules are given by 8 sessions over a 12-week period, with the initial 3 sessions every other day in the first week and the subsequent sessions every two weeks. The FMT regimen involves oral intake of 40 capsules per session. The best supportive care is performed when necessary, including oral medicine, enema, blood transfusion, and endoscopic procedures.
干预措施: Fecal Microbiota Transplantation Capsule (Biological)
结局指标
主要结局
Number of participants with mild rectal bleeding (grade 0-1)
时间窗: At the time of 12 weeks since the start of treatment
The symptom of rectal bleeding will be assessed by LENT-SOMA scales
次要结局
- Number of participants with mild rectal bleeding (grade 0-1)(At the time of 24 weeks since the start of treatment)
- Number of participants with improved colonoscopic findings(At the time of 12 and 24 weeks since the start of treatment)