About this trial
This study is a multicenter randomized controlled trial designed to investigate the effects of Clostridium butyricum on adverse events during adjuvant treatment for colorectal cancer.
Eligibility criteria
Qualifiers
Aged 18-70 years;
No restriction on gender;
Have completed radical resection for colorectal cancer (including open, laparoscopic, or robotic surgery), and assessed by the MDT as requiring adjuvant therapy primarily based on 5-FU and its derivatives or platinum-based regimens (including chemotherapy, targeted therapy, or radiotherapy);
ECOG performance status score of 0-2;
Disqualifiers
Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment;
Presence of psychiatric disorders or other conditions that prevent cooperation with the intervention;
Dysfunction of vital organs such as the liver, kidneys, or heart that renders the individual unsuitable for clinical research upon assessment, or inadequate bone marrow, liver, or renal function to undergo adjuvant therapy;
Participation in other clinical studies within 3 months prior to enrollment;
Trial design
Treatments tested in this trial
- Clostridium butyricum capsules
- placebo capsules
Treatment groups
Sponsors and collaborators
The Affiliated Hospital of Qingdao University
Lead sponsor
Shandong Provincial Hospital
Collaborator
Linyi People's Hospital
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Yantai Yuhuangding Hospital
Collaborator
Jining First People's Hospital
Collaborator
Rizhao People's Hospital
Collaborator
Qianfoshan Hospital
Collaborator
Weifang People's Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Taian City Central Hospital
Collaborator
The Affiliated Hospital of Shandong Second Medical University
Collaborator
Dongying People's Hospital
Collaborator