Clinical trial · Interventional
Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy
Streptococcus Salivarius K12 for Prevention and Treatment of Oral Mucositis in Patients Undergoing Radiotherapy for Head and Neck Tumor: A Randomized, Placebo-Controlled, Double-Blind Trial
NCT05918224CI-TRIAL-00073643completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of Streptococcus salivarius K12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Streptococcus salivarius K12 | Drug | — | UNRESOLVED |
| Streptococcus salivarius K12 simulants | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- S. salivarius K12 group: The S. salivarius K12 lozenges (NOW Foods, USA) contained not less than 1×109 CFU viable cells of S. salivarius K12 as the active ingredient. The S. salivarius K12 lozenges were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).
- interventionNames
- Drug: Streptococcus salivarius K12
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Placebo group: Placebo lozenges contained sugar and starch used as excipients in the active formulation. The placebo lozenge were dissolved in the mouth and then swallowed through the first day of RT to the end of treatment (1 lozenge 3 times a day).
- interventionNames
- Drug: Streptococcus salivarius K12 simulants
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with non-metastatic head and neck malignant tumor diagnosed by histopathology; * Aged 18 to 80 years; * Systemic functional status Eastern Cooperative Oncology Group (ECOG) (Appendix 1) rating ≤2; * Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy; * Sign the informed consent Exclusion Criteria: * Patients with known allergy to probiotic or severe allergic constitution; * Using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study; * Poor oral hygiene and/or severe periodontal diseases; * Any previous RT to the head and neck region; * Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
References
Publications (0)
Data not yet available
No reference posted for this study.