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Not yet recruiting NCT07152886

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

Phase IV Interventional Colorectal Cancer Chemotherapeutic Toxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clostridium butyricum capsules, placebo capsules.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Chemotherapeutic Toxicity. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effects of Clostridium Butyricum on Adverse Events During Adjuvant Chemotherapy for Colorectal Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial

Overview

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.

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.

Primary outcome measures

  • CTCAE grade 3-4 diarrhea [Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months]
Secondary outcome measures (10)
  • Overall incidence of adverse events [Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months]
  • rate of adjuvant treatment interruption [Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months]
  • White blood cell count [Time frame: 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 [Time frame: 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 [Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • C-reactive protein [Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • procalcitonin [Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • serum albumin [Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • serum procalcitonin [Time frame: Before the start of each cycle of adjuvant chemotherapy. A total of 6 to 8 cycles of chemotherapy are expected to be administered.]
  • completion rate of the planned adjuvant therapy [Time frame: Throughout the entire course of adjuvant chemotherapy , up to 6 months]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • The Affiliated Hospital of Qingdao University — Qingdao

Identifiers

NCT: NCT07152886 · DHQDFY-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗