NCT07309315

Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shenzhen Hospital of Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Chemotherapy-induced Diarrhea

Interventions

Type	Name	Description
DRUG	Inactivated Bacteroides fragilis	Live Biotherapeutic Products
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2025-12-30
• Last updated: 2025-12-30