A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Colorectal Neoplasms, Colorectal Adenoma, Colorectal Cancer, Advanced Adenoma
In brief
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.
Key facts
- Study ID
- NCT05592886
- Run by
- Chinese University of Hong Kong
- People needed
- 649
- Starts
- 2022-12-15
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-08-01
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)
- Inner Mongolia People's Hospital — Hohhot, Inner Mongolia, China
Full record on ClinicalTrials.gov
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