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).
Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures.
Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender.
Patients with malignant tumors confirmed by pathology or cytology.
Cohort 1: Patients with advanced colorectal cancer receiving the FOLFIRI regimen (irinotecan + fluorouracil + leucovorin);
History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization.
Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc.
Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy/treatment regimen specified in the protocol during the trial.
Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy.
Parallel
Inactivated Bacteroides fragilis
DrugLive Biotherapeutic Products
Placebo
DrugPlacebo
Overall Incidence of Diarrhea
Proportion of Patients with Any Grade of Diarrhea assessed by CTCAE v5.0
Incidence of Grade ≥2 Diarrhea
Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0
Incidence of Grade ≥3 Diarrhea
Proportion of Patients with Grade 2 or Higher Diarrhea assessed by CTCAE v5.0
Days of Diarrhea
Mean Days of Diarrhea per Treatment Cycle
Frequency of Diarrhea
Mean Frequency of Stool Type 6 or 7 per Treatment Cycle
Change in Levels of Blood Inflammatory Cytokines Compared with Baseline
Blood inflammatory cytokines Including but not limited to TNF-α, IL-6, IL-1β, IL-4, IL-10, IL-11, etc. Change in Levels of Blood Inflammatory Cytokines Compared with Baseline defined as the change in the levels of blood inflammatory cytokines of cancer patients after study intervention compared with the baseline.
Change in Composition and Diversity of Fecal Flora Structure, and Change in Fecal Metabolomics
Change in Composition and Diversity of Fecal Flora Structure defined as the change in the composition and diversity of fecal flora structure of cancer patients after study intervention compared with the baseline. Change in Fecal Metabolomics defined as the change in the fecal metabolomics of cancer patients after study intervention compared with the baseline.
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