The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
Live Biotherapeutic Products
Placebo
Overall Incidence of Diarrhea
Proportion of Patients with Any Grade of Diarrhea assessed by CTCAE v5.0
Time frame: 4 weeks
Incidence of Grade ≥2 Diarrhea
Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0
Time frame: 4 weeks
Incidence of Grade ≥3 Diarrhea
Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0
Time frame: 4 weeks
Days of Diarrhea
Mean Days of Diarrhea per Treatment Cycle
Time frame: 4 weeks
Frequency of Diarrhea
Mean Frequency of Stool Type 6 or 7 per Treatment Cycle
Time frame: 4 weeks
Percentage and Days of Patients Receiving Antidiarrheal Treatment
Percentage of patients treated with antidiarrheal drugs (loperamide, diphenoxylate, octreotide, montmorillonite), defined as the proportion of patients with at least one dose of antidiarrheal drugs relative to the total number of cases; days of antidiarrheal treatment, defined as the mean days of antidiarrheal drug administration per treatment cycle.
Time frame: 4 weeks
Proportion of Patients Who Received Medical Treatment for Diarrhea
Proportion of patients who sought medical attention due to diarrhea and received intravenous fluid replacement or anti-infective treatment from investigators.
Time frame: 4 weeks
Proportion of Patients Who Had Chemotherapy/Treatment Dose Reduction, Delay or Discontinuation Due to Diarrhea
Proportion of patients with chemotherapy/treatment dose reduction, delay or discontinuation as judged by investigators due to diarrhea.
Time frame: 4 weeks
Relative Dose Intensity of Chemotherapy/Treatment
Ratio of delivered dose intensity (mg/m² or mg) to planned dose intensity (mg/m² or mg)
Time frame: 4 weeks
Incidence of Other Gastrointestinal Symptoms
Proportion of patients with at least one episode of any grade of gastrointestinal symptoms (constipation, abdominal distension, abdominal pain, hematochezia, nausea, vomiting) assessed by CTCAE v5.0.
Time frame: 4 weeks
Change in Quality of Life Score of Cancer Patients Compared with Baseline
Defined as the change in the QLQ-C30 quality of life scale score of cancer patients after study intervention compared with the baseline.
Time frame: 4 weeks
Incidence of Adverse Event (AE)
Proportion of participants with adverse events as assessed by CTCAE v5.0
Time frame: 4 weeks
Incidence of Serious Adverse Event (SAE)
Proportion of participants with Serious Adverse Event (SAE) as assessed by GCP 2020
Time frame: 4 weeks
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