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

649 Participants
are divided into 2 treatment groups

Locations

2
China
Inner Mongolia People's Hospital HohhotInner Mongolia, China
Hong Kong
Prince of Wales Hospital Hong Kong Hong Kong

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor

Inner Mongolia People's Hospital

Collaborator