About this trial
This multicenter, double blinded randomized controlled trial aims to assess the efficacy of a novel oral synbiotic formula (SMT04) in reducing advanced adenoma recurrence and colorectal neoplasia-related bacterial gene markers after endoscopic resection of colorectal advanced neoplasia.
Eligibility criteria
Qualifiers
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SMT04 formula
- Active placebo
Treatment groups
Sponsors and collaborators
Chinese University of Hong Kong
Lead sponsor
Inner Mongolia People's Hospital
Collaborator