NCT06390176CompletedPhase 2
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 · Last updated 9 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 21 Apr 2024
- Start date
- 10 Nov 2023
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT06390176
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 10 Nov 2023 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking antifungal or viral medications one week prior to the start of radiation therapy.
Other illness
- Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
- History of head and neck radiotherapy;
- Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.
Other
- Those with poor compliance;
- Pregnancy or breastfeeding;
Who the study is looking for
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- Aged 18-80 years;
- Eastern Cooperative Oncology Group performance status of ≤2;
- Planning to receive definitive RT or postoperative adjuvant RT;
- Normal liver, kidney and bone marrow function;
- Sign informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.