这项多中心、双盲随机对照试验旨在评估一种新型口服合生元配方（SMT04）在结直肠晚期肿瘤内镜切除后减少晚期腺瘤复发及结直肠肿瘤相关细菌基因标记的疗效。
适应症：Colorectal Neoplasms、Colorectal Adenoma、Colorectal Cancer、Advanced Adenoma
入组条件
纳入标准
- Subjects who have advanced colorectal neoplasia\* removed and confirmed by histopathology;
- They have received high quality colonoscopies before or during endoscopic resection (defined as a full colonoscopy with successful caecal intubation, and a Boston Bowel Preparation Scale ≧2 in each colonic segment) with no residual colorectal neoplasia;
- Aged 18-90 years old;
- Written informed consent obtained
- An advanced colorectal neoplasia is defined as an advanced adenoma, sessile serrated lesion or non-invasive colorectal cancer (stage Tis or T1a). Advanced adenoma is defined as an adenoma larger than 10mm, and/or with villous component ≥20%, and/or harboring high grade dysplasia.
排除标准
- Known residual colorectal neoplasia not removed (except hyperplastic polyps);
- Contraindications to endoscopic resection due to deep submucosal invasion (stage T1b or above);
- Prior surgical resection of colon;
- Personal history of hereditary polyposis syndrome or inflammatory bowel disease;
- Known pregnancy or lactation;
- Immunocompromised status (e.g. on immunosuppressants (except 5-aminosalicylic acid or short term use of corticosteroids \<4 weeks), on chemotherapy, bone marrow or solid organ transplant, human immunodeficiency virus, congenital immune deficiency);
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
- Refusal to undergo surveillance colonoscopy.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。