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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* Subjects who have advanced colorectal neoplasia\* removed and confirmed by histopathology;
* 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:
* 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 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.
Primary outcome measure(s)
The incidence of metachronous recurrent advanced colorectal neoplasia at year 1 (local or at other sites). — 1 year The proportion of patients with metachronous recurrent advanced neoplasia at year 1
Trial sites (2)
Facility
City
Region
Status
Inner Mongolia People's Hospital
Hohhot
Inner Mongolia
Not Yet Recruiting
Prince of Wales Hospital
Hong Kong
Hong Kong
Recruiting
More Chinese University of Hong Kong trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.