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

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.

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Key information

Conditions

Colorectal Polyp Colorectal Adenoma Colorectal Cancer Recurrent

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing, China

Beijing, 100730, China

Location status: Recruiting

Location contact

Cheng Peng

CONTACT

[email protected]

+86 18500743525

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence

Time frame: 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 outcomes

Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Peng, MD

CONTACT

[email protected]

+86 18500743525

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: May 4, 2025
Registry last updated: Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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