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.