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

NCT05592886 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 649

Last updated 2025-08-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

SMT04 formula

The SMT04 formula is a synbiotic containing probiotics and prebiotics

OTHER

Active placebo

The 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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER
  • Inner Mongolia People's Hospital

    collaborator OTHER

Principal Investigators

  • Louis Lau · Prince of Wales Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2027-12-15
Completion
2027-12-31

Countries

  • China
  • Hong Kong

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592886 on ClinicalTrials.gov