Status:
NOT_YET_RECRUITING
The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Shandong Provincial Hospital
Linyi People's Hospital
Conditions:
Colorectal Cancer
Chemotherapeutic Toxicity
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
A total of 238 participants who have undergone radical resection for colorectal cancer and are scheduled to initiate adjuvant chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to the ...
Eligibility Criteria
Inclusion
- 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;
- Signed informed consent
Exclusion
- 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;
- History of inflammatory bowel disease;
- History of autoimmune diseases;
- Pregnancy or breastfeeding;
- Receipt of neoadjuvant therapy (including chemotherapy, radiotherapy, or targeted therapy) prior to surgery;
- Underwent ostomy surgery during the operation (including temporary or permanent ostomy).
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT07152886
Start Date
October 31 2025
End Date
December 31 2027
Last Update
September 3 2025
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266071