Actively Recruiting
A Multicenter, Double Blinded Randomized Controlled Trial of 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
2 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
Researchers are evaluating a new oral synbiotic formula called SMT04 to see if it can reduce the recurrence of advanced adenomas and related bacterial gene markers in people who have had colorectal advanced neoplasia removed. The study is a multicenter, double-blinded randomized controlled trial focused on colorectal cancer and its precancerous lesions, exploring how gut microbiome changes may influence disease progression and recurrence. The trial seeks to understand if SMT04 can sustain long-term benefits in lowering harmful bacterial markers linked to colorectal neoplasia. Participants will be randomly assigned to receive either the SMT04 synbiotic formula, which combines probiotics and heat-resistant prebiotics, or an active placebo containing a small amount of vitamin C and inert starch filler with matching appearance and flavor. The trial includes a control group receiving the placebo to compare effects. The SMT04 formula has previously been shown to increase beneficial Bifidobacterium species and reduce certain bacterial gene markers over weeks 2 to 12, but its long-term impact is still being studied. During the year-long study, participants will undergo monitoring to detect any recurrence of advanced colorectal neoplasia through colonoscopies and bacterial gene marker measurements. Researchers will track the incidence and number of recurrent adenomas and advanced neoplasia, as well as changes in bacterial gene markers and their correlation with disease recurrence. The primary outcome is the incidence of recurrent advanced colorectal neoplasia at one year. The study involves regular assessments, including colonoscopy quality checks and histopathological confirmation, to ensure thorough evaluation of treatment effects.
CONDITIONS
Brief 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
- Received high quality colonoscopies before or during endoscopic resection with no residual colorectal neoplasia
- Aged 18 to 90 years old
- Provided written informed consent
- Advanced colorectal neoplasia includes advanced adenoma, sessile serrated lesion, or non-invasive colorectal cancer (stage Tis or T1a)
- Advanced adenoma defined as adenoma larger than 10mm, 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 under 4 weeks, chemotherapy, transplant, HIV, congenital immune deficiency)
- Advanced comorbid conditions (American Society of Anesthesiologists grade 4 or above)
- Refusal to undergo surveillance colonoscopy
Research Team
L
Louis Lau
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