Changes in gut microbiome after removing colorectal tumors
A Pilot Study to Assess Serial Gut Microbiome and a Panel of Bacterial Gene Markers (M3) Changes After Endoscopic Resection of Colorectal Advanced Neoplasia
This study looks at how the bacteria in the gut change after people have surgery to remove colorectal tumors to see if these changes help with recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT05381792 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how the gut microbiome and specific bacterial gene markers change following the endoscopic resection of advanced colorectal neoplasia. It aims to understand the relationship between gut bacteria and the restoration of microbiome health after treatment. The study will involve patients who require endoscopic procedures for colorectal adenomas or early-stage cancer, and it will analyze microbiome samples before and after the intervention. The findings could provide insights into the role of gut microbiota in colorectal cancer progression and recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 who require endoscopic resection for advanced adenoma or early-stage colorectal cancer.
Not a fit: Patients with contraindications to colonoscopy or endoscopic resection, as well as those with advanced comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding of gut health and potential strategies for colorectal cancer prevention.
How similar studies have performed: While some studies have explored microbiome changes in colorectal cancer, this specific approach focusing on post-resection changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects require endoscopic resection (e.g. endoscopic mucosal resection or endoscopic submucosal dissection) for advanced adenoma or early-stage colorectal cancer; * Aged 18-90 years old; * Written informed consent obtained. Exclusion Criteria: * Absolute contraindications to colonoscopy (e.g. perforation, intestinal obstruction, unstable cardiopulmonary status); * Contraindications to endoscopic resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets); * Known pregnancy or lactation; * Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above);
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Min Dai
- Email: mindai@link.cuhk.edu.hk
- Phone: 6049 0760
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.