Charlene Enhui Goh, Rohan Williams, Nitasha Gupta, Francis Ho, Intekhab Islam, Clement Wei Ming Lai, Kai Soo Tan, Catherine Hsu Ling Hong
{"title":"罗伊氏乳酸杆菌益生菌对头颈部放疗患者口腔黏膜炎的影响：一项随机试验。","authors":"Charlene Enhui Goh, Rohan Williams, Nitasha Gupta, Francis Ho, Intekhab Islam, Clement Wei Ming Lai, Kai Soo Tan, Catherine Hsu Ling Hong","doi":"10.1111/odi.70083","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Limited management strategies exist for cancer therapy-induced oral mucositis (OM).</p><p><strong>Materials and methods: </strong>We conducted a randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of Limosilactobacillus reuteri (LR) probiotic to prevent and reduce the severity of OM in head and neck cancer patients undergoing radiotherapy (RT). Patients ≥ 21 years requiring head and neck RT of ≥ 60 Gy and those undergoing concurrent chemotherapy with RT (CCRT) with no prior OM were recruited. OM incidence and severity were assessed weekly from baseline to two weeks post-RT. Oral samples were collected at baseline and study mid-point to profile microbiome changes.</p><p><strong>Results: </strong>Overall, no significant differences in OM incidence or severity (grade ≥ 3) were observed between LR and placebo groups. However, subgroup analyses of participants who received RT-only showed significantly lower mean OM scores (-0.42; 95% CI: -0.75, -0.09; p = 0.02) over time in the LR probiotic group. Beta diversity of the oral microbiome was significantly different between the RT-only probiotic and placebo groups (PERMANOVA: F = 1.77; R<sup>2</sup> = 0.07; p = 0.025). No serious adverse effects were observed in the LR group.</p><p><strong>Conclusion: </strong>LR probiotic use was safe and associated with a reduced OM incidence and severity in RT-only participants. These findings are promising and provide important insights for future studies in larger cohorts.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT03552458.</p>","PeriodicalId":19615,"journal":{"name":"Oral diseases","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of Limosilactobacillus reuteri Probiotic on Oral Mucositis in Patients Undergoing Head and Neck Radiation: A Randomised Trial.\",\"authors\":\"Charlene Enhui Goh, Rohan Williams, Nitasha Gupta, Francis Ho, Intekhab Islam, Clement Wei Ming Lai, Kai Soo Tan, Catherine Hsu Ling Hong\",\"doi\":\"10.1111/odi.70083\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Limited management strategies exist for cancer therapy-induced oral mucositis (OM).</p><p><strong>Materials and methods: </strong>We conducted a randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of Limosilactobacillus reuteri (LR) probiotic to prevent and reduce the severity of OM in head and neck cancer patients undergoing radiotherapy (RT). Patients ≥ 21 years requiring head and neck RT of ≥ 60 Gy and those undergoing concurrent chemotherapy with RT (CCRT) with no prior OM were recruited. OM incidence and severity were assessed weekly from baseline to two weeks post-RT. Oral samples were collected at baseline and study mid-point to profile microbiome changes.</p><p><strong>Results: </strong>Overall, no significant differences in OM incidence or severity (grade ≥ 3) were observed between LR and placebo groups. However, subgroup analyses of participants who received RT-only showed significantly lower mean OM scores (-0.42; 95% CI: -0.75, -0.09; p = 0.02) over time in the LR probiotic group. Beta diversity of the oral microbiome was significantly different between the RT-only probiotic and placebo groups (PERMANOVA: F = 1.77; R<sup>2</sup> = 0.07; p = 0.025). No serious adverse effects were observed in the LR group.</p><p><strong>Conclusion: </strong>LR probiotic use was safe and associated with a reduced OM incidence and severity in RT-only participants. These findings are promising and provide important insights for future studies in larger cohorts.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT03552458.</p>\",\"PeriodicalId\":19615,\"journal\":{\"name\":\"Oral diseases\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oral diseases\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/odi.70083\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DENTISTRY, ORAL SURGERY & MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oral diseases","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/odi.70083","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DENTISTRY, ORAL SURGERY & MEDICINE","Score":null,"Total":0}
引用次数: 0
摘要
目的：肿瘤治疗性口腔黏膜炎（OM）的治疗策略有限。材料和方法：我们进行了一项随机、双盲、安慰剂对照试验，以评估罗伊氏乳杆菌（LR）益生菌预防和减轻头颈癌放疗（RT）患者OM严重程度的有效性和安全性。≥21岁需要≥60 Gy头颈部放射治疗的患者，以及既往无OM的同时接受化疗与放射治疗（CCRT）的患者被招募。从基线到放疗后两周，每周评估OM的发病率和严重程度。在基线和研究中点收集口腔样本，以描述微生物组的变化。结果：总体而言，LR组和安慰剂组在OM发生率或严重程度（≥3级）方面无显著差异。然而，仅接受rt治疗的参与者的亚组分析显示，随着时间的推移，LR益生菌组的平均OM评分显著降低（-0.42;95% CI: -0.75, -0.09; p = 0.02）。口服益生菌组和安慰剂组的β多样性有显著差异（PERMANOVA: F = 1.77; R2 = 0.07; p = 0.025）。LR组未见严重不良反应。结论：使用LR益生菌是安全的，并且在仅接受rt治疗的参与者中与降低OM发病率和严重程度相关。这些发现是有希望的，并为未来更大规模的研究提供了重要的见解。试验注册：ClinicalTrials.gov: NCT03552458。
Effect of Limosilactobacillus reuteri Probiotic on Oral Mucositis in Patients Undergoing Head and Neck Radiation: A Randomised Trial.
Objective: Limited management strategies exist for cancer therapy-induced oral mucositis (OM).
Materials and methods: We conducted a randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of Limosilactobacillus reuteri (LR) probiotic to prevent and reduce the severity of OM in head and neck cancer patients undergoing radiotherapy (RT). Patients ≥ 21 years requiring head and neck RT of ≥ 60 Gy and those undergoing concurrent chemotherapy with RT (CCRT) with no prior OM were recruited. OM incidence and severity were assessed weekly from baseline to two weeks post-RT. Oral samples were collected at baseline and study mid-point to profile microbiome changes.
Results: Overall, no significant differences in OM incidence or severity (grade ≥ 3) were observed between LR and placebo groups. However, subgroup analyses of participants who received RT-only showed significantly lower mean OM scores (-0.42; 95% CI: -0.75, -0.09; p = 0.02) over time in the LR probiotic group. Beta diversity of the oral microbiome was significantly different between the RT-only probiotic and placebo groups (PERMANOVA: F = 1.77; R2 = 0.07; p = 0.025). No serious adverse effects were observed in the LR group.
Conclusion: LR probiotic use was safe and associated with a reduced OM incidence and severity in RT-only participants. These findings are promising and provide important insights for future studies in larger cohorts.
期刊介绍：
Oral Diseases is a multidisciplinary and international journal with a focus on head and neck disorders, edited by leaders in the field, Professor Giovanni Lodi (Editor-in-Chief, Milan, Italy), Professor Stefano Petti (Deputy Editor, Rome, Italy) and Associate Professor Gulshan Sunavala-Dossabhoy (Deputy Editor, Shreveport, LA, USA). The journal is pre-eminent in oral medicine. Oral Diseases specifically strives to link often-isolated areas of dentistry and medicine through broad-based scholarship that includes well-designed and controlled clinical research, analytical epidemiology, and the translation of basic science in pre-clinical studies. The journal typically publishes articles relevant to many related medical specialties including especially dermatology, gastroenterology, hematology, immunology, infectious diseases, neuropsychiatry, oncology and otolaryngology. The essential requirement is that all submitted research is hypothesis-driven, with significant positive and negative results both welcomed. Equal publication emphasis is placed on etiology, pathogenesis, diagnosis, prevention and treatment.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
