Clinical trial · Interventional
Effects of Probiotics in Preventing Oral Mucositis
Effects of Probiotics Intake on Oral Microbiome and Mucosa Inflammation in Patients With Cytotoxic Therapy Induced Oral Mucositis: A Pilot Study
NCT03552458CI-TRIAL-00038368unknownPhase 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)
The study will be a randomized double blind prospective placebo controlled clinical study and aims to determine the therapeutic efficacy of Probiotics in Oral Mucositis pathogenesis in patients undergoing head and neck radiotherapy.
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 Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus Reuteri Oral Solution [BioGaia] | Drug | — | UNRESOLVED |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LR group
- description
- Lactobacillus Reuteri Oral Solution \[BioGaia\]
- interventionNames
- Drug: Lactobacillus Reuteri Oral Solution [BioGaia]
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Placebos: The control agent will not contain the active agent
- interventionNames
- Drug: Placebos
Primary outcomes (5)
- measure
- Oral Mucositis (OM) Severity Assessment
- timeFrame
- Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients who are 21 years of age or older 2. histological diagnosis of head and neck carcinoma available 3. undergoing head and neck radiotherapy of at least 6000cGY 4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 5. no known allergy to Biogaia 6. able to give written informed consent, or have written consent given on their behalf. Exclusion Criteria: 1. patients who cannot use the products or have it administered to them 2. patients with existing conditions predisposing to oral ulcer formation 3. patients with mucositis at baseline (prior to initiation of treatment) 4. previous radiotherapy to the head and neck region 5. female patients who are pregnant or breastfeeding 6. patients who have central venous catheters 7. patients who have impaired intestinal epithelial barrier 8. patients who have cardiac valvular disease 9. unable to give written informed consent, or are unable to have written consent given on their behalf. 10. inability to converse in English or Mandarin 11. severe immunosuppression (Absolute Neutrophil Count of less than 1500 cells/µL)
References
Publications (1)
- DERIVEDGoh CE, Williams R, Gupta N, Ho F, Islam I, Lai CWM, Tan KS, Hong CHL. Effect of Limosilactobacillus reuteri Probiotic on Oral Mucositis in Patients Undergoing Head and Neck Radiation: A Randomised Trial. Oral Dis. 2026 Feb;32(2):480-491. doi: 10.1111/odi.70083. Epub 2025 Aug 31. PMID 40887814