Autologous Fecal Microbiota Transplantation Via the Diverting Stoma Ameliorates Diversion Colitis in Patients With Temporary Ileostomy for Rectal Cancer: A Randomized Controlled Trial With Endoscopic and Histopathological Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Endoscopic Score
研究概览
简要总结
Diversion colitis (DC) is a common inflammatory complication in patients with temporary ileostomy after rectal cancer surgery, and no standardized medical treatment exists. This prospective, assessor-blinded, parallel-group, randomized controlled trial evaluated whether autologous fecal microbiota transplantation (auto-FMT) delivered through the diverting stoma ameliorates DC and improves post-reversal outcomes. Sixty-six patients with endoscopically confirmed DC were randomized 1:1 to receive daily auto-FMT (n=33) or saline irrigation (n=33) for four weeks. The primary endpoints are changes from baseline to week 4 in endoscopic (modified Harig score, 0-12) and histopathological (0-9) scores. Secondary endpoints include Wexner incontinence score, quality of life (EORTC QLQ-C30/CR29), inflammatory biomarkers, and safety. The study is designed to test whether auto-FMT produces superior improvements in endoscopic and histopathological severity compared with saline control, and leads to better functional outcomes after stoma reversal.
详细描述
Background and Rationale
Diversion colitis frequently develops after fecal stream diversion, affecting most patients whose intestinal continuity remains interrupted for more than three to six months. While stoma reversal is definitive, many patients require prolonged diversion due to adjuvant chemotherapy, poor general condition, or anastomotic healing concerns. Existing medical therapies-including short-chain fatty acid enemas, 5-aminosalicylates, corticosteroids, and probiotics-lack consistent efficacy in randomized trials. Gut microbiota dysbiosis is a central driver of DC; restoring a diverse microbial community via fecal microbiota transplantation represents a rational approach. Autologous FMT using the patient's own stoma effluent avoids pathogen transmission, donor screening, and ethical concerns. However, no prospective RCT has systematically evaluated auto-FMT for DC using endoscopic and histopathological endpoints.
Study Design
Single-center, prospective, assessor-blinded, parallel-group, superiority randomized controlled trial with a 1:1 allocation ratio.
Participants
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
- Single (Outcomes Assessor)
盲法说明
Outcome Assessor and Statistician were blinded.
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
- •Histopathologically confirmed rectal adenocarcinoma.
- •Low anterior resection with temporary loop ileostomy.
- •Age 18-75 years.
- •Scheduled for ileostomy reversal at 3-6 months after primary surgery.
- •Endoscopic confirmation of diversion colitis at week 4 post-ileostomy (modified Harig score ≥4, range 0-12).
- •Written informed consent.
排除标准
- •Neoadjuvant chemoradiotherapy.
- •Pre-existing inflammatory bowel disease, irritable bowel syndrome, or chronic constipation.
- •Previous colorectal surgery (other than index surgery).
- •Active infection requiring systemic antibiotics within 4 weeks before enrollment.
- •Use of probiotics, prebiotics, or antibiotics within 4 weeks before enrollment.
- •Severe organ dysfunction (Child-Pugh B/C cirrhosis, end-stage renal disease).
- •Pregnancy or lactation.
- •Any condition precluding protocol compliance or outcome assessment.
研究组 & 干预措施
Autologous Fecal Microbiota Transplantation (auto-FMT)
Daily irrigations of autologous fecal microbiota suspension via the diverting stoma for 4 weeks. Preparation: 50-80 g of fresh stool collected from the patient's stoma bag within 2 hours of passage, homogenized with 500 mL of sterile normal saline (0.9% NaCl) pre-warmed to 37 °C, stirred, and filtered through two layers of sterile gauze. The filtrate is used within 30 minutes. Irrigation: A 14-16 French Foley catheter inserted 10-15 cm into the efferent limb of the loop ileostomy, balloon inflated with 5-8 mL of air. The suspension is infused by gravity drip (bag 40-50 cm above stoma) over 5-10 minutes. Patients retain the suspension for at least 30 minutes before evacuation. Vital signs are monitored for the first 3 days.
干预措施: Autologous Fecal Microbiota Transplantation (auto-FMT) (Other)
Saline Irrigation
Daily irrigations of 500 mL sterile normal saline (0.9% NaCl) pre-warmed to 37 °C via the diverting stoma for 4 weeks. A 14-16 French Foley catheter is inserted 10-15 cm into the efferent limb of the loop ileostomy, and the balloon is inflated with 5-8 mL of air. Saline is infused by gravity drip (bag 40-50 cm above stoma) over 5-10 minutes. Patients retain the saline for at least 30 minutes before evacuation.
干预措施: saline irrigation (Other)
结局指标
主要结局
Change in Endoscopic Score
时间窗: Baseline and Week 4
Change from baseline to week 4 in modified Harig score (0-12), evaluating edema/erythema, loss of vascular pattern, friability/contact bleeding, and erosions/ulcerations (each 0-3). Higher scores indicate more severe inflammation. A blinded colorectal endoscopist performed colonoscopy through the stoma at week 0 and week 4.
Change in Histopathological Score
时间窗: Baseline and Week 4
Change from baseline to week 4 in composite histopathological score (0-9), assessing mucosal atrophy, crypt distortion, and inflammatory infiltrate (each 0-3). The average score of two blinded gastrointestinal pathologists was used; disagreements (\>2 points) were resolved by joint review.
次要结局
- Wexner Incontinence Score(Month 1, Month 3, Month 6 post-reversal)
- Quality of Life - EORTC QLQ-C30 Global Health Status(Baseline, Week 4, and Month 6 post-reversal)
- Quality of Life - EORTC QLQ-CR29(Baseline, Week 4, and Month 6 post-reversal)
- Serum hs-CRP Level(Baseline and Week 4)
- Serum Albumin Level(Baseline and Week 4)
- Fecal Calprotectin Level(Baseline and Week 4)
- Adverse Events and Treatment Adherence(Throughout the 4-week intervention period for adverse events; at end of intervention for adherence)
研究者
Yongjian Liao
First People's Hospital Of Lin'an District, Hangzhou
First People's Hospital Of Lin'an District, Hangzhou