A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
NCT ID: NCT05592886
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
649 participants
INTERVENTIONAL
2022-12-15
2027-12-31
Brief Summary
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Detailed Description
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Probiotics, including the genera Bifidobacterium and Lactobacillus, have shown to be able to inhibit tumorigenesis and progression of CRC in animal studies. Prebiotics are non-digestible dietary ingredients with protective effects against cancer by selectively stimulating the growth and activity of beneficial colonic microbiota. The combination of probiotics and prebiotics, known as synbiotic, may be more efficient in preventing CRC than either one alone.
The investigators' unpublished data showed that the new probiotic formula containing Bifidobacterium strains has a negative correlation with CRC-related bacterial gene markers. Subjects treated with SMT04 showed significantly higher levels of the individual Bifidobacterium species at week 2 to week 5 compared with baseline levels. There was a significant decrease in the bacterial gene markers (Fn, m3 and 4Bac CRC risk score) from week 2 to week 12 compared with baseline levels in the SMT04 group but not in the control group. The synbiotic formula (SMT04) is the combination of probiotic formula and several heat-resistant prebiotics. It remains unclear that whether this synbiotic formula can produce a sustained effect in reduction of advanced adenoma recurrence and colorectal neoplasia related bacterial gene markers in long-term.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention arm
Receive SMT04 formula
SMT04 formula
The SMT04 formula is a synbiotic containing probiotics and prebiotics
Placebo arm
Receive active placebo
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.
Interventions
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SMT04 formula
The SMT04 formula is a synbiotic containing probiotics and prebiotics
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* An advanced colorectal neoplasia is defined as an advanced adenoma, sessile serrated lesion or non-invasive colorectal cancer (stage Tis or T1a). Advanced adenoma is defined as an adenoma larger than 10mm, and/or with villous component ≥20%, and/or harboring high grade dysplasia.
Exclusion Criteria
* 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 use of corticosteroids \<4 weeks), on chemotherapy, bone marrow or solid organ transplant, human immunodeficiency virus, congenital immune deficiency);
* Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
* Refusal to undergo surveillance colonoscopy.
18 Years
90 Years
ALL
No
Sponsors
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Inner Mongolia People's Hospital
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
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Louis Ho Shing Lau
Clinical Assistant Professor
Principal Investigators
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Louis Lau
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital
Locations
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Inner Mongolia People's Hospital
Hohhot, Inner Mongolia, China
Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Louis Lau
Role: primary
Other Identifiers
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2022.360
Identifier Type: -
Identifier Source: org_study_id
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