Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06957626

Enrollment

150

Registered

2025-05-04

Start date

2023-04-25

Completion date

2026-04-30

Last updated

2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Adenoma, Colorectal Cancer Recurrent, Colorectal Polyp

Brief summary

The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. Additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence	24 months	Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with high-risk colorectal polyp recurrence or without recurrence.

Secondary

Measure	Time frame	Description
Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy	36 months	Select the recurrence and non-recurrence of polyps during the follow-up period , and develop and validate the recurrence prediction model according to the differences in intestinal mucosal flora and host gene expression levels.

Countries

China

Contacts

Primary ContactCheng Peng, MD

pengchengf@mail.sdu.edu.cn+86 18500743525

Outcome results