NCT06285591

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The goal of this clinical trial is to evaluate the efficacy and safety of Lactobacillus reuteri in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Lactobacillus reuteri can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy. Participants will be instructed to suck a Lactobacillus reuteri or placebo lozenge twice daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour. Researchers will compare Lactobacillus reuteri group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.

Conditions

• Head and Neck Malignant Tumors

Interventions

Type	Name	Description
DRUG	Lactobacillus reuteri Tablets	Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10\^8 CFU viable cells of Lactobacillus reuteri as the active ingredient.
DRUG	Placebo-containing tablets	The placebo lozenges shared the same formulation as the L. reuteri lozenges but without the probiotic, whose appearance, taste, and color were identical to those of the Lactobacillus reuteri lozenges.
RADIATION	Radiotherapy	One of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-02-29
• Last updated: 2025-12-19

Locations

1 site across 1 country: China