Clinical trial · Interventional
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
NCT06285591CI-TRIAL-00099344completedPhase 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 Lactobacillus reuteri 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 Malignant Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus reuteri Tablets | Drug | — | UNRESOLVED |
| Placebo-containing tablets | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Placebo-containing tablets
- interventionNames
- Drug: Placebo-containing tablets
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Lactobacillus reuteri tablets
- interventionNames
- Drug: Lactobacillus reuteri Tablets
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 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. Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy; 5. Sign informed consent. Exclusion Criteria: 1. Patients with known allergy to probiotic or severe allergic constitution; 2. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study; 3. Poor oral hygiene and/or severe periodontal diseases; 4. History of head and neck radiotherapy; 5. 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.