CMTS0515 - Augmented Washed Microbiota Transplantation Versus Washed Microbiota Transplantation in Radiation Enteritis: A Randomized, Double-Blind, Non-inferiority Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The clinical response rate after treatment
研究概览
简要总结
This is a randomized controlled trial to explore the exploring the non-inferiority of CMTS0515-augmented WMT compared to WMT.
详细描述
At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the experimental group (CMTS0515-augmented WMT) and the control group (WMT). Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed diagnosis of abdominal or pelvic cancer;
- •Completion of at least one entire course of radiation therapy;
- •Age ≥18 years at the time of cancer diagnosis.
排除标准
- •Absence of intestinal symptoms or transient intestinal symptoms;
- •Radiation treatment involving areas outside the abdomen and pelvis;
- •Diagnosis of antibiotic-associated diarrhea or use of antibiotics within four weeks before enrollment;
- •Presence of intestinal comorbidities, including inflammatory bowel disease or pseudomembranous colitis;
- •Presence of severe conditions rendering the patient unsuitable for inclusion;
- •Experience of bowel surgery for RE-associated fistula.
研究组 & 干预措施
CMTS0515-augmented washed microbiota transplantation
Patients undergo CMTS0515-augmented washed microbiota transplantation once a day for three consecutive days.
干预措施: CMTS0515-augmented washed microbiota transplantation (Other)
washed microbiota transplantation
Patients undergo washed microbiota transplantation once a day for three consecutive days.
干预措施: Washed Microbiota Transplantation (Other)
结局指标
主要结局
The clinical response rate after treatment
时间窗: 1 week, 4 weeks and 8 weeks
Radiation Therapy Oncology Group (RTOG) scores
次要结局
- Scores of gastrointestinal symptoms(1 week, 4 weeks and 8 weeks)
- Stool frequency and consistency(1 week, 4 weeks and 8 weeks)
研究者
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University