๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โง2 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 โฅ20%, 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.
๐
What it tests
- SMT04 formula
- Active placebo
Inner Mongolia People's Hospital
Hohhot, China
Prince of Wales Hospital
Hong Kong, Hong Kong
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.