The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.
Age between 18 and 75 years
No restriction on sex
Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure
Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically
Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment
Presence of psychiatric disorders or other conditions preventing compliance with the intervention
Dysfunction of vital organs (liver, kidney, heart, etc.) deemed unsuitable for clinical study participation after evaluation
Participation in other clinical trials within 3 months prior to enrollment
Parallel
Clostridium butyricum capsules, Live
DrugOral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum).
Control (placebo)
Other interventionPlacebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.
The 3-year cumulative recurrence rate of CRA
The 3-year cumulative recurrence rate of CRA following colonoscopic resection. Recurrence is defined as the identification of new or residual adenomatous polyps in the colorectum on colonoscopy during the follow-up period, confirmed pathologically.
1-year and 2 year adenoma recurrence rate
Each subject will undergo a colonoscopy once per year after enrollment to monitor for adenoma recurrence.
incidence of colorectal cancer
Each subject will undergo a colonoscopy once per year after enrollment to monitor for the development of colorectal cancer. The incidence of colorectal cancer is calculated as: Incidence (%) = (Number of subjects diagnosed with colorectal cancer / Total number of subjects) × 100%
Incidence of advanced colorectal adenomas
Each subject will undergo a colonoscopy once per year after enrollment to monitor for the presence of advanced adenomas. The incidence of advanced adenomas is calculated as: Incidence (%) = (Number of subjects with advanced adenomas / Total number of subjects) × 100% Advanced colorectal adenoma is diagnosed when any of the following criteria are met: Adenoma diameter ≥ 10 mm，Villous component ≥ 25%，Presence of high-grade intraepithelial neoplasia.
Location of adenoma recurrence
Classify the locations according to ascending colon, transverse colon, descending colon, sigmoid colon, and rectum.
Changes in gut microbiota composition
Changes in gut microbiota composition assessed by 16S rRNA sequencing of fecal samples collected at baseline and every 6 months during the follow-up period.
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The Affiliated Hospital of Qingdao University
Lead sponsor
Shandong Cancer Hospital and Institute
Collaborator
Yantai Yuhuangding Hospital
Collaborator
Rizhao People's Hospital
Collaborator
Qianfoshan Hospital
Collaborator
Weifang People's Hospital
Collaborator
Dongying People's Hospital
Collaborator
Peking University People's Hospital
Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborator
The First Affiliated Hospital of Bengbu Medical University
Collaborator
