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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer; Chemotherapeutic Toxicity
• Interventions: Drug: Clostridium butyricum capsules; Other: placebo capsules

• Registration Number: NCT07152886
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

Detailed Description

A total of 238 participants who have undergone radical resection for colorectal cancer and are scheduled to initiate adjuvant chemotherapy will be enrolled and randomly assigned in a 1:1 ratio to the intervention group or the control group. During adjuvant chemotherapy, participants in the intervention group will receive Clostridium butyricum capsules, while those in the control group will receive a placebo. The primary outcome is the incidence of CTCAE grade 3-4 diarrhea during adjuvant chemotherapy.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-10-31
• Primary Completion: 2027-10-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 238

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Clostridium butyricum capsules	Oral administration of Clostridium butyricum capsules during adjuvant chemotherapy, 6 capsules tid. (each capsule containing ≥6.3 × 10⁶ CFU of Clostridium butyricum).
control group	placebo capsules	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.

Primary Outcome Measures

Name	Time	Method
CTCAE grade 3-4 diarrhea	Throughout the entire course of adjuvant chemotherapy , up to 6 months	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

Secondary Outcome Measures

Name	Time	Method
Overall incidence of adverse events	Throughout the entire course of adjuvant chemotherapy , up to 6 months	Overall incidence of adverse events during adjuvant chemotherapy. Severity and specific types will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
rate of adjuvant treatment interruption	Throughout the entire course of adjuvant chemotherapy , up to 6 months	defined as a delay of \>=3 weeks from the planned treatment schedule
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.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
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.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
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.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
C-reactive protein	Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
procalcitonin	Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
serum albumin	Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
serum procalcitonin	Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.	Blood samples will be collected and tested before the start of each cycle of adjuvant chemotherapy to obtain the results.
completion rate of the planned adjuvant therapy	Throughout the entire course of adjuvant chemotherapy , up to 6 months	The total number of adjuvant chemotherapy cycles will be determined by the MDT (Multidisciplinary Team) prior to the initiation of treatment. Completion of the planned number of cycles as specified will be defined as "completed."

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China