Limosilactobacillus reuteri for oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors: a randomized controlled trial.
11 affiliations
- 1Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
- 2Sichuan Provincial Key Laboratory of Nuclear Physics and Medical Research, Sichuan University, Chengdu, Sichuan, China.
- 3Department of Oncology and Radiotherapy Center, Chengdu Seventh People's Hospital, Chengdu, China.
- 4Department of Oncology, The General Hospital of Western Theater Command, Chengdu, Sichuan, China.
- 5Department of Medical Education, Kweichow Moutai Hospital, Zunyi, Guizhou, China.
- 6Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, China.
- 7Division of Head & Neck Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
- 8Institute of Hospital Management, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
- 9Clinical Research Management Office, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
- 10Department of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, China. [email protected].
- 11Sichuan Provincial Key Laboratory of Nuclear Physics and Medical Research, Sichuan University, Chengdu, Sichuan, China. [email protected].
Abstract
Oral mucositis (OM) is a major toxicity in patients with head and neck cancer undergoing radiotherapy. Here we conducted a double-blind, placebo-controlled, randomized phase II trial (NCT06285591) from March 2024 to January 2025 at West China Hospital of Sichuan University to evaluate whether Limosilactobacillus reuteri (L. reuteri) supplementation could reduce severe OM (SOM; WHO Oral Toxicity criteria grade ≥3). A total of 160 patients were randomly assigned to receive L. reuteri probiotic lozenges or placebo twice daily during radiotherapy. The primary endpoint was the incidence of SOM, and secondary endpoints included SOM onset and duration, as well as the incidence, onset, and duration of any-grade OM. Safety outcomes were monitored throughout the study. The primary endpoint was met, with a lower incidence of SOM in the L. reuteri group than in the placebo group (37.5% vs 61.3%; relative risk 0.61; 95% confidence interval 0.44-0.85; absolute risk reduction 23.8 percentage points, 95% CI 8.7% to 38.8%; P = 0.004). L. reuteri supplementation also delayed SOM onset and shortened SOM duration. No significant safety concerns were observed. These findings indicate that L. reuteri supplementation reduces SOM incidence and severity in patients with head and neck cancer receiving radiotherapy.
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BibTeX
@article{gao2026limosilactobacillus,
title = {{Limosilactobacillus reuteri for oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors: a randomized controlled trial.}},
author = {Kun Gao and Yuan-Tai Li and Yi-Yan Pei and Zhi-Hui Li and Jia-Gang He and Zheng Jiang and Zhe-Ran Liu and Yu Min and Zi-Xia Li and Ping Ai and Shu-Ming Ji and Wen-Yan Guo and Xing-Chen Peng},
journal = {Nature communications},
year = {2026},
month = sep,
doi = {10.1038/s41467-026-78088-6},
url = {https://europepmc.org/article/MED/42957718},
note = {CC BY},
}
RIS
TY - JOUR
TI - Limosilactobacillus reuteri for oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors: a randomized controlled trial.
AU - Kun Gao
AU - Yuan-Tai Li
AU - Yi-Yan Pei
AU - Zhi-Hui Li
AU - Jia-Gang He
AU - Zheng Jiang
AU - Zhe-Ran Liu
AU - Yu Min
AU - Zi-Xia Li
AU - Ping Ai
AU - Shu-Ming Ji
AU - Wen-Yan Guo
AU - Xing-Chen Peng
PY - 2026
DA - 2026/09/29
JO - Nature communications
DO - 10.1038/s41467-026-78088-6
UR - https://europepmc.org/article/MED/42957718
AB - Oral mucositis (OM) is a major toxicity in patients with head and neck cancer undergoing radiotherapy. Here we conducted a double-blind, placebo-controlled, randomized phase II trial (NCT06285591) from March 2024 to January 2025 at West China Hospital of Sichuan University to evaluate whether Limosilactobacillus reuteri (L. reuteri) supplementation could reduce severe OM (SOM; WHO Oral Toxicity criteria grade ≥3). A total of 160 patients were randomly assigned to receive L. reuteri probiotic lozenges or placebo twice daily during radiotherapy. The primary endpoint was the incidence of SOM, and secondary endpoints included SOM onset and duration, as well as the incidence, onset, and duration of any-grade OM. Safety outcomes were monitored throughout the study. The primary endpoint was met, with a lower incidence of SOM in the L. reuteri group than in the placebo group (37.5% vs 61.3%; relative risk 0.61; 95% confidence interval 0.44-0.85; absolute risk reduction 23.8 percentage points, 95% CI 8.7% to 38.8%; P = 0.004). L. reuteri supplementation also delayed SOM onset and shortened SOM duration. No significant safety concerns were observed. These findings indicate that L. reuteri supplementation reduces SOM incidence and severity in patients with head and neck cancer receiving radiotherapy.
SN - 2041-1723
ER -