At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Lactobacillus reuteri Tablets, Placebo-containing tablets, and 1 other intervention for Head and Neck Malignant Tumors. Completed, enrolled 160 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10\^8 CFU viable cells of Lactobacillus reuteri as the active ingredient.
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.
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.