Predicting recurrence of high-risk colorectal polyps using microbiota and metabolites
Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
This study is trying to see if the bacteria and substances in the gut can help predict if high-risk colorectal polyps will come back after they've been removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06957626 on ClinicalTrials.gov |
What this trial studies
This study analyzes the characteristics of intestinal microbiota in patients who have undergone polypectomy for high-risk colorectal polyps. It aims to understand the relationship between microbial communities and the recurrence of these polyps, which could provide insights into the etiology of adenoma recurrence. By developing a prediction model based on microbiota and metabolites, the research seeks to enhance patient management and outcomes following polypectomy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40-75 years who have at least one high-risk colorectal polyp and are undergoing colonoscopy.
Not a fit: Patients with severe physical diseases, previous gastrointestinal surgeries, or existing colorectal cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a predictive tool that helps identify patients at higher risk for polyp recurrence, allowing for more tailored surveillance and intervention strategies.
How similar studies have performed: While the specific approach of using microbiota and metabolites for prediction is novel, similar studies have shown promise in understanding the role of microbiota in colorectal health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged 40-75 years who undergo the colonoscopy with at least 1 advanced premalignant polyps or ≥ 3 adenoma Exclusion Criteria: * patient with severe physical diseases that prevented them from adhering to the examination requirements, * patient with coagulopathy or other contraindications for biopsy or polypectomy, * patient with previous surgical procedures on the gastrointestinal tract, * presence of colorectal cancer or other malignant tumor at baseline * presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or Lynch syndrome) * within 1 month before enrollment, oral antibiotics and probiotics were taken; * inability to provide informed consent or refusal to participate in the study.
Where this trial is running
Beijing
- Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing, China — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Cheng Peng, MD
- Email: pengchengf@mail.sdu.edu.cn
- Phone: +86 18500743525
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.