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

NCT06446180 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-06-25

No results posted yet for this study

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

Conditions

  • Oral Mucositis

Interventions

DRUG

SsK12@Lip@GSH

SsK12@Lip@GSH powder contained 1×10\^9 CFU viable cells of SsK12@Lip@GSH as the active ingredient.

Sponsors & Collaborators

  • The General Hospital of Western Theater Command

    lead OTHER

Principal Investigators

  • zhihui li · The General Hospital of Western Theater Command

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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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 NCT06446180 on ClinicalTrials.gov