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

Qingdao University

Status and phase: Not yet enrolling; Phase 4

Conditions: Chemotherapeutic Toxicity; Colorectal Cancer

Treatments: Other: placebo capsules; Drug: Clostridium butyricum capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT07152886

DHQDFY-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

238 participants in 2 patient groups, including a placebo group

intervention group

Experimental group

Description:

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

Treatment:

Drug: Clostridium butyricum capsules

control group

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo capsules