protocolSection identificationModule nctId: NCT06285591, orgStudyIdInfo id: 2023-1801, briefTitle: Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: 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 Reuteri is a natural flora of the human body that can be found in the gastrointestinal tract, skin, etc. Among them, Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can be isolated from healthy mammals as well as poultry, and are common Lactobacillus strains marketed for the production of oral probiotics, which are commonly used in infant formulas, among others. In oral inflammatory diseases, it has been reported in the literature that Lactobacillus Reuteri DSM 17938 and ATCC PTA 5289 can reduce gingival and periodontal inflammation, mainly through the mechanisms of modulating the host inflammatory response and displacing pathogenic bacteria. In terms of safety, oral Lactobacillus Reuteri has good stability, very low pathogenic potential, and is not toxic to humans. Therefore, this study is a placebo-controlled, multi-center, open, randomized controlled clinical study to evaluate the efficacy of Lactobacillus Reuteri for the prevention of radioactive oral mucosal reactions in intensity-modulated radiotherapy for head and neck tumors, including nasopharyngeal carcinoma., conditionsModule conditions: Oral Mucositis (Ulcerative) Due to Radiation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Lactobacillus Reuteri Tablets, interventions name: Placebo-containing tablets, interventions name: Radiotherapy, outcomesModule primaryOutcomes measure: The incidence of Severe Oral mucositis (WHO grade ≥3), primaryOutcomes measure: The time to onset of Severe Oral mucositis (WHO grade ≥3), primaryOutcomes measure: The duration of Severe Oral mucositis (WHO grade ≥3), secondaryOutcomes measure: Taste function, secondaryOutcomes measure: Xerostomia summated xerostomia inventory (SXI), secondaryOutcomes measure: Functional assessment of cancer therapy-head and neck (FACT- H&N) quality of life questionnaire, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Oral activities scores, secondaryOutcomes measure: Mouth and throat soreness (MTS) scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Xingchen Peng, PhD, role: CONTACT, phone: +86 18980606753, email: pxx2014@163.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False