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Clinical Trials in China / NCT05592886
Recruiting Not applicable

A Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers

NCT05592886 · tracked via the Priya Life Science China tracker
Sponsor
Chinese University of Hong Kong
Phase
Not applicable
Started
2022-12-15
Last updated
2025-08-01

Condition(s) studied

Colorectal NeoplasmsColorectal AdenomaColorectal CancerAdvanced Adenoma

Investigational drug(s) / intervention(s)

SMT04 formulaActive placebo

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)

Trial sites (2)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05592886 on ClinicalTrials.gov ↗ ← All trials in China