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
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
- Colorectal Neoplasms
- Colorectal Adenoma
- Colorectal Cancer
- Advanced Adenoma
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
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