Oral MucositisPhase 1NCT06446180
Streptococcus Salivarius K12@Lip@GSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
A Phase 1 study testing SsK12@Lip@GSH in people with Oral Mucositis, run by The General Hospital of Western Theater Command at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- SsK12@Lip@GSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2024to 12 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1.Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
- 2.Those with poor compliance;
- 3.Pregnancy or breastfeeding;
- 4.History of head and neck radiotherapy;
- 5.Taking antifungal or viral medications one week prior to the start of radiation therapy.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology，The General Hospital of Western Theater Command
Chengdu, Sichuan, 610083
About this study
Official title: 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
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
Read the detailed description
Radiotherapy (RT) is an important method of treatment for malignant tumors of the head and neck and can be used alone or in combination with chemotherapy as a radical or adjuvant therapy. Despite improvements in RT equipment and techniques, various acute oral complications persist, including oral mucositis (OM), dry mouth, taste dysfunction, and oral infections. OM is one of the most common acute radiation-related toxicities, and approximately 50%-70% of patients experience severe OM (SOM) defined by the WHO scale as grade 3 to 4. The painful inflammation and ulceration associated with OM not only profoundly affect patients' ability to eat, swallow, and speak, but also decrease their tolerance to anti-cancer treatment, thereby, impairing their quality of life (QoL) significantly and causing interruptions in their cancer treatment. Although some clinical strategies for radiation-induced OM have been recommended by the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) , their efficacy and safety still need further clinical validation. Recent evidence suggests the involvement of oral microbiota in radiationinduced OM, and modulation of oral microbiota is promising for the management of OM. Streptococcus salivarius K12 is a commercially available oral probiotic with strong oral colonization ability, bacteriocin-like inhibitory substance (BLIS)-producing capability, and immunomodulatory properties, and has been used to treat oral candidiasis, pharyngitis, tonsillitishalitosis, and otitis media. More importantly, data from our recent animal study demonstrated that topical use of S. salivarius K12 ameliorates radiationinduced OM in mice by modulating the oral microbiota, mainly by suppressing oral anaerobes.
the investigatorsprevious studies that have reported the use of single SSK12 probiotics in RIOM. In 2024, the applicant team published a randomized controlled trial as the first author in the top journal in the field of oncology, Journal o f Clinical Oncology, which found that Streptococcus salivarius K12 (SSK12) can effectively alleviate RIOM in radiotherapy patients with malignant head and neck tumors.
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 evaluated the treatment outcome of SSK12@Lip@GSH on RIOM mice .
In vitro studies showed that SSK12@Lip@GSH treatment was beneficial for the healing of RIOM mice, as reflected by reduced ulcer size, increased basal layer epithelial cellularity and mucosal thickness, and elevated epithelial proliferation and attenuated apoptosis. Genomic results showed that the SSK12@Lip@GSH could improve relevant mRNA pathways to promote RIOM healing. In addition, SSK12@Lip@GSH treatment reconstituted the oral microbiota and decreased the abundance of oral anaerobes of RIOM mice.Therefore, the SSK12@Lip@GSH holds promise as a potential approach for preventing and treating radiation-induced oral mucositis.
- Conditions
- Oral Mucositis
- Being tested
- SsK12@Lip@GSH
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SsK12@Lip@GSHDrug
SsK12@Lip@GSH powder contained 1×10^9 CFU viable cells of SsK12@Lip@GSH as the active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | SsK12@Lip@GSH Receives: Drug: SsK12@Lip@GSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
The duration of Severe Oral mucositis (WHO grade ≥3)
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Mouth and throat soreness (MTS) scores
Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Xerostomia summated xerostomia inventory (SXI)
Xerostomia is subjectively assessed on the Summated Xerostomia Inventory (SXI). The SXI is categorized according to score as 0 no dry mouth (5), 1 mild dry mouth (6-8), 2 moderate dry mouth (9-12), and 3 severe (13-15).
Measured: 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
FACT- H\&N quality of life questionnaire 4.0 is a scale used to assess quality of life in
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Oral activities scores
Patients report the degree to the impact of MTS on oral activities (including swallowing, drinking, eating, talking, sleeping) (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms
Measured: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start7 Jun 2024
- Primary completion10 Aug 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihui Li, The General Hospital of Western Theater Command
- Investigators
- zhihui li, Principal investigator, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446180
- Sponsor's protocol ID
- 2024-002
- Status last verified
- Jun 2025
- First submitted
- 9 May 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06446180
- Acronym / sponsor ID
- 2024-002
- Conditions
- Oral Mucositis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Radiotherapy (RT) is an important method of treatment for malignant tumors of the head and neck and can be used alone or in combination with chemotherapy as a radical or adjuvant therapy. Despite improvements in RT equipment and techniques, various acute oral complications persist, including oral mucositis (OM), dry mouth, taste dysfunction, and oral infections. OM is one of the most common acute radiation-related toxicities, and approximately 50%-70% of patients experience severe OM (SOM) defined by the WHO scale as grade 3 to 4. The painful inflammation and ulceration associated with OM not only profoundly affect patients' ability to eat, swallow, and speak, but also decrease their tolerance to anti-cancer treatment, thereby, impairing their quality of life (QoL) significantly and causing interruptions in their cancer treatment. Although some clinical strategies for radiation-induced OM have been recommended by the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology (MASCC/ISOO) , their efficacy and safety still need further clinical validation. Recent evidence suggests the involvement of oral microbiota in radiationinduced OM, and modulation of oral microbiota is promising for the management of OM. Streptococcus salivarius K12 is a commercially available oral probiotic with strong oral colonization ability, bacteriocin-like inhibitory substance (BLIS)-producing capability, and immunomodulatory properties, and has been used to treat oral candidiasis, pharyngitis, tonsillitishalitosis, and otitis media. More importantly, data from our recent animal study demonstrated that topical use of S. salivarius K12 ameliorates radiationinduced OM in mice by modulating the oral microbiota, mainly by suppressing oral anaerobes.
the investigatorsprevious studies that have reported the use of single SSK12 probiotics in RIOM. In 2024, the applicant team published a randomized controlled trial as the first author in the top journal in the field of oncology, Journal o f Clinical Oncology, which found that Streptococcus salivarius K12 (SSK12) can effectively alleviate RIOM in radiotherapy patients with malignant head and neck tumors.
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 evaluated the treatment outcome of SSK12@Lip@GSH on RIOM mice .
In vitro studies showed that SSK12@Lip@GSH treatment was beneficial for the healing of RIOM mice, as reflected by reduced ulcer size, increased basal layer epithelial cellularity and mucosal thickness, and elevated epithelial proliferation and attenuated apoptosis. Genomic results showed that the SSK12@Lip@GSH could improve relevant mRNA pathways to promote RIOM healing. In addition, SSK12@Lip@GSH treatment reconstituted the oral microbiota and decreased the abundance of oral anaerobes of RIOM mice.Therefore, the SSK12@Lip@GSH holds promise as a potential approach for preventing and treating radiation-induced oral mucositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: SsK12@Lip@GSHSsK12@Lip@GSH |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 1.Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
- 2.Those with poor compliance;
- 3.Pregnancy or breastfeeding;
- 4.History of head and neck radiotherapy;
- 5.Taking antifungal or viral medications one week prior to the start of radiation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SsK12@Lip@GSHSsK12@Lip@GSH powder contained 1×10^9 CFU viable cells of SsK12@Lip@GSH as the active ingredient. | Drug | Experimental group |
Primary outcome
The incidence of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
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.
7 secondary outcomes
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
The duration of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Mouth and throat soreness (MTS) scores
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Xerostomia summated xerostomia inventory (SXI)
Time frame: 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
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Adverse events
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Oral activities scores
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhihui li principal investigator
The General Hospital of Western Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SsK12@Lip@GSH in people with Oral Mucositis, run by The General Hospital of Western Theater Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Severe Oral mucositis (WHO grade ≥3) (time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.