Clostridium butyricum capsules: Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
placebo capsules: Oral 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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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).
Primary outcome measure(s)
CTCAE grade 3-4 diarrhea — Throughout the entire course of adjuvant chemotherapy , up to 6 months 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
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
More The Affiliated Hospital of Qingdao University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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