Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Patients With Rectal Cancer: A Prospective, Single-center, Single-arm, Open-label Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
研究概览
简要总结
This prospective, single-center, single-arm, open-label clinical study aims to evaluate whether autologous fecal microbiota transplantation can improve bowel and anal function after ileostomy reversal in patients with rectal cancer who underwent radical rectal cancer surgery with protective loop ileostomy. Eligible patients will receive autologous fecal microbiota transplantation before ileostomy reversal. The primary outcome is the Low Anterior Resection Syndrome score at 3 months after ileostomy reversal. Secondary outcomes include fecal incontinence score, colonoscopic findings before ileostomy reversal, gut microbiota profiles, inflammatory markers, anorectal manometry, pelvic floor electromyography, and safety outcomes.
详细描述
Patients with rectal cancer who undergo radical resection with protective loop ileostomy may experience diversion-related changes in the distal bowel, gut microbiota dysbiosis, diversion colitis, and impaired bowel function after ileostomy reversal. Autologous fecal microbiota transplantation may help restore the intestinal microbial environment in the defunctioned bowel and improve postoperative bowel function.
In this study, eligible patients will undergo standard radical rectal cancer surgery with protective loop ileostomy. At approximately 8 weeks after surgery, patients without severe postoperative complications such as anastomotic leakage will undergo anal swab sampling for 16S rRNA gene sequencing. Autologous fecal microbiota transplantation will be performed once weekly at postoperative weeks 8, 9, 10, and 11. At approximately 12 weeks after surgery, colonoscopy will be performed to evaluate the distal bowel mucosa, and intestinal secretion samples will be collected for 16S rRNA gene sequencing. Ileostomy reversal will then be performed according to routine clinical practice. Bowel function will be followed for 3 months after ileostomy reversal, with the primary endpoint being the LARS score at 3 months after reversal.
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 to 75 years.
- •Histologically or clinically confirmed rectal cancer with the lower tumor margin less than 12 cm from the anal verge.
- •Undergoing radical rectal cancer surgery with protective loop ileostomy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Able to understand the study procedures and willing to provide written informed consent.
排除标准
- •History of inflammatory bowel disease, bacterial colitis, or other preoperative colonic inflammatory disease.
- •Requirement for emergency surgery due to intestinal obstruction, perforation, bleeding, or other emergency conditions.
- •Pregnant or lactating women.
- •Presence of clinically significant gut microbiota dysbiosis before enrollment, as judged by the investigator.
- •Planned postoperative radiotherapy, chemotherapy, or chemoradiotherapy.
- •Poor compliance, inability to tolerate the intervention, or judged by the investigator to be unsuitable for participation in this clinical study.
- •Severe postoperative complications such as anastomotic leakage.
结局指标
主要结局
Low Anterior Resection Syndrome Score at 3 Months After Ileostomy Reversal
时间窗: 3 months after ileostomy reversal
Low Anterior Resection Syndrome (LARS) score will be assessed using the LARS questionnaire at 3 months after ileostomy reversal. The total score ranges from 0 to 42 points, with higher scores indicating more severe bowel dysfunction. Scores of 0-20 indicate no LARS, 21-29 indicate minor LARS, and 30-42 indicate major LARS.
次要结局
- Colonoscopic Mucosal Findings Before Ileostomy Reversal(Approximately 12 weeks after initial surgery and before ileostomy reversal)
研究者
Shen Zhanlong
Professor
Peking University People's Hospital