Actively Recruiting
A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
Led by Chinese University of Hong Kong · Updated on 2025-08-01
649
Participants Needed
2
Research Sites
263 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
I
Inner Mongolia People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who have advanced colorectal neoplasia removed and confirmed by histopathology
- Have received high quality colonoscopies before or during endoscopic resection with no residual colorectal neoplasia
- Aged 18 to 90 years old
- Written informed consent obtained
- Advanced colorectal neoplasia includes advanced adenoma, sessile serrated lesion, or non-invasive colorectal cancer (stage Tis or T1a)
- Advanced adenoma is defined as an adenoma larger than 10 mm, and/or with villous component 60%, and/or harboring high grade dysplasia
You will not qualify if you...
- 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
- Known pregnancy or lactation
- Immunocompromised status (e.g., on immunosuppressants except 5-aminosalicylic acid or short term corticosteroids less than 4 weeks, chemotherapy, bone marrow or solid organ transplant, HIV, congenital immune deficiency)
- Advanced comorbid conditions (American Society of Anesthesiologists grade 4 or above)
- Refusal to undergo surveillance colonoscopy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Not Yet Recruiting
2
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
L
Louis Lau
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here