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
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