The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer
NCT ID: NCT07152886
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
238 participants
INTERVENTIONAL
2025-10-31
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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intervention group
Oral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
Clostridium butyricum capsules
Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
control group
Oral administration of placebo capsules, 6 capsules three times daily, containing corn starch. The appearance and weight of the placebo capsules are identical to those of intervention group.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
70 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Linyi People's Hospital
OTHER
Shandong Cancer Hospital and Institute
OTHER
Yantai Yuhuangding Hospital
OTHER
Jining First People's Hospital
OTHER
Rizhao People's Hospital
OTHER
Qianfoshan Hospital
OTHER
Weifang People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Taian City Central Hospital
OTHER
The Affiliated Hospital of Shandong Second Medical University
UNKNOWN
Dongying People's Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Zhou Yanbing
The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University
Principal Investigators
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Yanbing Zhou
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Locations
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Gan Liu
Role: primary
Other Identifiers
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DHQDFY-02
Identifier Type: -
Identifier Source: org_study_id
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