The Effects of Bifidobacterium and Lactobacillus Tablets Combined With Compound Glutamine in the Prevention and Treatment of Radiation Proctitis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Incidence of radiation proctitis
研究概览
简要总结
Radiation proctitis is a common complication after radiation therapy for pelvic tumors. The investigators found that live bifidobacterium and lactobacillus tablets combined with compound glutamine enteric-coated capsules can significantly relieve the symptoms of radiation proctitis through preliminary clinical practice, but the mechanism is unknown. Through a prospective randomized controlled study, this study intends to investigate the incidence of grade 2 or higher acute radiation proctitis in patients of locally advanced rectal cancer after radiotherapy with the combined therapy. And through various scales, next-generation sequencing methods and other methods to evaluate the clinical symptoms, colonoscopy, imaging, and changes in the species and abundance of intestinal flora before and after treatment. To further explore the related pathways and mechanisms affecting radiation proctitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •locally advanced rectal adenocarcinoma diagnosed by histopathology; clinical stage T3/4 or N+(AJCC,8th), no metastasis; and planned to receive preoperative neoadjuvant concurrent chemoradiotherapy.
- •without other malignant tumors;
- •Those without serious heart, liver, kidney and other diseases;
- •ECOG score: 0-1.
排除标准
- •Complicated with ulcerative colitis or Crohn's disease;
- •Complicated with severe organ insufficiency, severe diabetes, and heart disease;
- •Pregnant and lactating women;
- •Abnormal bowel movements with systemic and metabolic diseases;
- •The patient has a history of using systemic antibiotics and intestinal active bacteria in the past 1 month.
研究组 & 干预措施
combination therapy group
From the first day of chemoradiotherapy, live combined Bifidobacterium and Lactobacillus tablets(2000mg each time, 3 times/day) combined with compound glutamine enteric-coated capsules (3 capsules each time, 3 times/day) until 1 month after the end of chemoradiotherapy.
干预措施: Live Combined Bifidobacterium and Lactobacillus Tablets、Compound Glutamine Entersoluble capsules (Drug)
结局指标
主要结局
Incidence of radiation proctitis
时间窗: two months
Incidence of grade ≥2 radiation proctitis in combination therapy group
次要结局
- remission rate of radiation proctitis(two months)