NCT06285591CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 6 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- West China Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT06285591
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 1 Mar 2024 to the primary completion date, 1 Jan 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
- Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Other illness
- Patients with known allergy to probiotic or severe allergic constitution;
- Poor oral hygiene and/or severe periodontal diseases;
- History of head and neck radiotherapy;
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;
- Receiving definitive RT or postoperative adjuvant RT at a dose of 60-72Gy with/without concurrent chemotherapy;
- Sign informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept 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.