New oral synbiotic formula to reduce colorectal adenoma recurrence
A Multicenter, Double Blinded Randomized Controlled Trial of a Novel Oral Synbiotic Formula in Reducing Advanced Adenoma Recurrence and Colorectal Neoplasia-related Bacterial Gene Markers
This study is testing a new oral formula made of probiotics and prebiotics to see if it can help prevent the return of certain growths in the colon after they've been removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 649 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Hohhot, Inner Mongolia and 1 other locations) |
| Trial ID | NCT05592886 on ClinicalTrials.gov |
What this trial studies
This double-blinded randomized controlled trial evaluates the effectiveness of a novel oral synbiotic formula (SMT04) in preventing the recurrence of adenomas and reducing bacterial gene markers associated with colorectal neoplasia after endoscopic resection. The study is based on the premise that gut microbiome alterations contribute to colorectal cancer progression, and aims to leverage the combined effects of probiotics and prebiotics to restore a healthy microbiota. Participants will receive either the active synbiotic formula or a placebo, and their outcomes will be monitored for signs of adenoma recurrence and changes in bacterial markers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 with advanced colorectal neoplasia requiring endoscopic resection.
Not a fit: Patients with known residual colorectal neoplasia, prior surgical resections, or those who are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of colorectal cancer recurrence in patients with a history of adenomas.
How similar studies have performed: Previous studies have indicated potential success with similar synbiotic approaches in cancer prevention, although this specific formulation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hohhot, Inner Mongolia and 1 other locations
- Inner Mongolia People's Hospital — Hohhot, Inner Mongolia, China (Not_yet_recruiting)
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Louis Lau — Prince of Wales Hospital
- Study coordinator: Louis Lau
- Email: louishslau@cuhk.edu.lhk
- Phone: 35052211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.