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

NCT06446180 | Completed Phase 1

• 1 other identifier: 2024-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence of Severe Oral mucositis (WHO grade ≥3)

  Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

Secondary Outcomes (7)

• The time to onset of Severe Oral mucositis (WHO grade ≥3)

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• The duration of Severe Oral mucositis (WHO grade ≥3)

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• Mouth and throat soreness (MTS) scores

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• Xerostomia summated xerostomia inventory (SXI)

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

• Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire

  From the start of radiotherapy to 4 weeks after completion of radiotherapy

Study Arms (1)

Experimental group

EXPERIMENTAL

SsK12@Lip@GSH

Drug: SsK12@Lip@GSH

Interventions

SsK12@Lip@GSH DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
• \. Aged 18-80 years;
• \. Eastern Cooperative Oncology Group performance status of ≤2;
• \. Planning to receive definitive RT or postoperative adjuvant RT;
• \. Normal liver, kidney and bone marrow function;
• \. Sign informed consent.

You may not qualify if:

• Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
• Those with poor compliance;
• Pregnancy or breastfeeding;
• History of head and neck radiotherapy;
• Taking antifungal or viral medications one week prior to the start of radiation therapy.
• Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.

Sponsors & Collaborators

• The General Hospital of Western Theater Command: lead

Study Sites (1)

Department of Oncology，The General Hospital of Western Theater Command

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• zhihui li

  The General Hospital of Western Theater Command

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,Professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: June 6, 2024
• Study Start: June 7, 2024
• Primary Completion: August 10, 2024
• Study Completion: September 12, 2024
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)