Clinical trial · Interventional
Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus rhamnosus GG (LGG) is a type of lactic acid bacterium, which is an important component of the microbiota in many parts of the human body. Lactobacillus rhamnosus GG (LGG) is a lactic acid bacterium found in the human body, extensively researched for its probiotic properties. It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma. LGG adheres well to epithelial layers, produces a protective biofilm, and modulates immune responses. It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula. Additionally, a daily dosage of 3×10\^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects
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 |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lactobacillus rhamnosus GG | Dietary Supplement | — | UNRESOLVED |
| Placebo-containing tablets | Dietary Supplement | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Placebo-containing tablets
- interventionNames
- Dietary Supplement: Placebo-containing tablets
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Lactobacillus rhamnosus GG (LGG)
- interventionNames
- Dietary Supplement: Lactobacillus rhamnosus GG
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- The incidence of Severe Oral mucositis (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. Planning to receive definitive RT or postoperative adjuvant RT; 5. Normal liver, kidney and bone marrow function; 6. Sign informed consent. Exclusion Criteria: 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.
References
Publications (0)
Data not yet available