The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorecta… (NCT07152886) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer
China238 participantsStarted 2025-10-31
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
CTCAE grade 3-4 diarrhea
Timeframe: Throughout the entire course of adjuvant chemotherapy , up to 6 months
Trial details
NCT IDNCT07152886
SponsorThe Affiliated Hospital of Qingdao University