drugset / Trial / NCT06446180

Streptococcus Salivarius K12@Lip@GSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy

NCT06446180 ↗

Phase 1 Completed 22 enrolled The General Hospital of Western Theater Command
NaSingle-groupOpen-labelTreatment

Summary

Radiation-induced oral mucositis (RIOM) is the most common oral complication of cancer patients receiving radiotherapy and/or chemotherapy, leading to poor quality of life. the investigators previous studies that have reported the use of single SSK12 probiotics in RIOM. However, SSK12 probiotics alone may lack stability, free radical scavenging activity and oral local targeting.Here, the investigators designed a new oral probiotic K12@Lip@GSH that SSK12 is encapsulated in liposomes(Lip) to enhance its stability and free radical scavenging ability, and glutathione (GSH) transporter-mediated oral targeting agent based on the over-expression of GSH transporters at the RIOM. The investigators have complete evaluated the treatment outcome of SSK12@Lip@GSH on RIOM mice. The investigators designed a single-center, single-arm prospective clinical study to evaluate the safety and efficacy of SsK12@Lip@GSH in the treatment of radioactive oral mucositis in patients with head and neck malignancies

Timeline

Start
2024-06-07
Primary completion
2024-08-10
Completion
2024-09-12

Drugs

EvaluationDrugModalityDoseRoute
Subject SSK12@Lip@GSH Other / unclassified 1e+09 cells —

Indications