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.
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
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;
Parallel
SMT04 formula
Other interventionThe SMT04 formula is a synbiotic containing probiotics and prebiotics
Active placebo
Other interventionThe active placebo is 2 mg Vitamin C with an inert substance made of starch filler. The flavor, coloring and appearance are unidentifiable to the study product.
The incidence of metachronous recurrent advanced colorectal neoplasia at year 1 (local or at other sites).
The proportion of patients with metachronous recurrent advanced neoplasia at year 1
Incidence of recurrent colorectal adenomas at year 1
The proportion of patients with metachronous recurrent adenoma at year 1
Number of recurrent advanced neoplasia at year 1
The number of recurrent colorectal advanced neoplasia per patient both in intervention and placebo arm
Number of recurrent adenomas at year 1
The number of recurrent colorectal adenoma per patient both in intervention and placebo arm
Changes in the levels of bacterial gene markers
The change in the level of four bacterial gene markers and combined risk score tested by qPCR
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Chinese University of Hong Kong
Lead sponsor
Inner Mongolia People's Hospital
Collaborator
