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.
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;
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;
Parallel
Clostridium butyricum capsules
DrugClostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
placebo capsules
Other interventionOral administration of placebo capsules, 6 capsules tid., containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.
CTCAE grade 3-4 diarrhea
Incidence of grade 3-4 diarrhea during adjuvant chemotherapy, with severity graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Overall incidence of adverse events
Overall incidence of adverse events during adjuvant chemotherapy. Severity and specific types will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
rate of adjuvant treatment interruption
defined as a delay of \>=3 weeks from the planned treatment schedule
White blood cell count
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
neutrophil count
Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
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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
This trial is not recruiting at the moment. You can still explore other options:
