The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Clostridium butyricum capsules
  • placebo capsules

Treatment groups

238 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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