【摘要】 目的 通过分析婴幼儿食品中菌种的临床试验的中英文相关文献基本情况，描述其研究领域的现状及研究热点，为我国制定可用于婴幼儿食品菌种的临床试验指南提供参考依据。方法 采用共词分析法和聚类分析法，对PubMed、中国知网资源总库（CNKI）等4个数据库来源的“婴幼儿食品中菌种临床试验”期刊论文进行统计分析。结果 国内年度发文量是国外的10倍；全球排名前3位的国家分别为意大利、中国和美国；国外研究机构主要为大学，国内研究机构主要为医院及妇幼保健院；国外研究主题热点主要为鼠李糖乳杆菌和罗伊氏乳杆菌系列菌株，应用于腹泻、婴儿绞痛和新生儿坏死性小肠结肠炎等疾病；国内研究主题热点主要为益生菌制剂培菲康在坏死性小肠结肠炎、米雅在腹泻以及思连康结合光疗或中医药疗法治疗新生儿黄疸的应用。结论 我国应该加强对婴幼儿食用菌种或益生菌药物临床试验的监管和审批，并尽快制定相应的临床试验指南。更多还原

【Abstract】 Objective This study aimed to provide valuable insights into the current state and research trends of clinical trials involving probiotics in infant foods. The analysis of Chinese and English articles sheds light on critical areas for the development of clinical trial guidelines for probiotic use in infant foods in China.Methods A comprehensive analysis was conducted on journal articles reporting clinical trials of probiotics in infant foods obtained from databases such as PubMed and CNKI. Co-word analysis and cluster analysis were employed to explore research themes and trends.Results Chinese publications in this field outnumbered English publications by a factor of 10. Italy, China, and the United States were the top three countries contributing to this research. Foreign research institutions were predominantly universities, while Chinese research institutions were primarily hospitals and maternal and child health hospitals. Foreign research hotspots included the use of Lactobacillus rhamnosus and Lactobacillus reuteri strains in managing conditions like diarrhea, infantile colic, and neonatal necrotizing enterocolitis. In China, the primary research focus areas included the application of Peifeikang for necrotizing enterocolitis, Miya for diarrhea, and Siliankang in combination with phototherapy or traditional Chinese medicine for neonatal jaundice.Conclusion China should enhance supervision and approval procedures for clinical trials involving probiotics in infant foods and promptly establish corresponding clinical trial guidelines.更多还原