A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorChinese University of Hong Kong

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

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor

Inner Mongolia People's Hospital

Collaborator