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

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.

Conditions

• Colorectal Cancer
• Chemotherapeutic Toxicity

Interventions

DRUG

Clostridium butyricum capsules

Clostridium butyricum capsules , 6 capsules tid (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).

OTHER

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.

Sponsors & Collaborators

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Linyi People's Hospital

  collaborator OTHER

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Jining First People's Hospital

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Taian City Central Hospital

  collaborator OTHER

• The Affiliated Hospital of Shandong Second Medical University

  collaborator UNKNOWN

• Dongying People's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  lead OTHER

Principal Investigators

• Yanbing Zhou · The Affiliated Hospital of Qingdao University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2027-10-31

Completion

2027-12-31

Countries

• China

Study Locations