NCT06446180CompletedPhase 1
Streptococcus Salivarius K12@Lip@GSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
Streptococcus Salivarius K12@Lip@GSH preventsOral Mucositis in Patients Undergoingintensity Modulated Radiotherapy for Malignant Head and Neck Tumors(Including Nasopharyngeal Carcinoma) : A Single, Single Arm Prospective Trial
Source: ClinicalTrials.gov · Last updated 25 Jun 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 9 May 2024
- Start date
- 7 Jun 2024
- Primary completion date
- 10 Aug 2024
- Lead sponsor
- The General Hospital of Western Theater Command
- Diseases
- Head and neck cancer
- NCT number
- NCT06446180
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 22
- From 7 Jun 2024 to the primary completion date, 10 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 5.Taking antifungal or viral medications one week prior to the start of radiation therapy.
Other illness
- 1.Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
- 4.History of head and neck radiotherapy;
- 6.Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.
Other
- 2.Those with poor compliance;
- 3.Pregnancy or breastfeeding;
Who the study is looking for
- 1\. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- 2\. Aged 18-80 years;
- 3\. Eastern Cooperative Oncology Group performance status of ≤2;
- 4\. Planning to receive definitive RT or postoperative adjuvant RT;
- 5\. Normal liver, kidney and bone marrow function;
- 6\. Sign informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology，The General Hospital of Western Theater Command Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.