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Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea

NCT07309315 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-30

No results posted yet for this study

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

DRUG

Inactivated Bacteroides fragilis

Live Biotherapeutic Products

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Shenzhen Hospital of Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-03-30
Completion
2026-03-30

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309315 on ClinicalTrials.gov