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

NCT07152886 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: DHQDFY-02
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colorectal Cancer; adjuvant chemotherapy; Clostridium butyricum

Outcome Measures

Primary Outcomes (1)

• CTCAE grade 3-4 diarrhea

  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

  Throughout the entire course of adjuvant chemotherapy , up to 6 months

Secondary Outcomes (10)

• Overall incidence of adverse events

  Throughout the entire course of adjuvant chemotherapy , up to 6 months

• rate of adjuvant treatment interruption

  Throughout the entire course of adjuvant chemotherapy , up to 6 months

• White blood cell count

  Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.

• neutrophil count

  Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.

• lymphocyte count

  Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.

Study Arms (2)

intervention group

EXPERIMENTAL

Oral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).

Drug: Clostridium butyricum capsules

control group

PLACEBO COMPARATOR

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.

Other: placebo capsules

Interventions

Clostridium butyricum capsules DRUG

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

intervention group

placebo capsules OTHER

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.

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• 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

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266071, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yanbing Zhou

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gan Liu

CONTACT

18866799842; docliu163@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants who meet the inclusion criteria after screening will receive either the investigational product or placebo, packaged and labeled with a unique randomization number, as assigned by an independent investigator. The participants, as well as the researchers involved in recruitment, screening, and follow-up, and the nursing staff, will all be blinded to the group assignments. Unblinding and data analysis will be conducted only after all participants have completed adjuvant chemotherapy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)