Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Diabetes. Jul 15, 2025; 16(7): 106821
Published online Jul 15, 2025. doi: 10.4239/wjd.v16.i7.106821
Lactobacillus rhamnosus LRa05 on glycemic control and gut microbiota in patients with type 2 diabetes
Lin Geng, Ting-Ting Sun, Wen-Bo Xia, Yin Qin, Di Huo, Guang-Jing Qu
Lin Geng, Ting-Ting Sun, Wen-Bo Xia, Yin Qin, Di Huo, Guang-Jing Qu, Department of Second Inpatient, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, Heilongjiang Province, China
Lin Geng, Ting-Ting Sun, Wen-Bo Xia, Yin Qin, Di Huo, Guang-Jing Qu, National Clinical Research Center for Geriatric Diseases, PLA General Hospital, Beijing 100853, China
Author contributions: Lin G contributed to conceptualization, methodology, software, and writing the original draft; Sun TT contributed to data curation, formal analysis, and investigation; Xia WB contributed to formal analysis, investigation, and methodology; Qin Y contributed to supervision and formal analysis; Huo D contributed to software and validation; Qu GJ contributed to conceptualization, project administration, and reviewing and editing; All authors read and approved the final manuscript.
Institutional review board statement: Our study received approval from the Ethics Committee of the First Affiliated Hospital of Harbin Medical University approved this study (IRB-AF/SC-04-02).
Clinical trial registration statement: The trial was registered at Chinese Clinical Trial Registry (https: //www.chictr.org.cn/bin/home) , number ChiCTR2300073308.
Informed consent statement: Informed consent was obtained from all individual participants included in the study.
Conflict-of-interest statement: The authors declare that there are no conflicts of interest.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Data sharing statement: All data generated and analyzed during this study are included in the manuscript.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Guang-Jing Qu, Department of Second Inpatient, The First Affiliated Hospital of Harbin Medical University, No. 23 Post Street, Nangang District, Harbin 150001, Heilongjiang Province, China. quguangjing2022@126.com
Received: March 10, 2025
Revised: March 26, 2025
Accepted: May 22, 2025
Published online: July 15, 2025
Processing time: 129 Days and 20.2 Hours
Abstract
BACKGROUND

Type 2 diabetes mellitus (T2DM) is a metabolic disorder linked to high blood glucose and gut dysbiosis. Probiotics like Lactobacillus rhamnosus LRa05 may improve glycemic control and gut microbiota.

AIM

To explore the impact of LRa05 with hypoglycemic medications on glycemic control and intestinal flora in T2DM patients with gut dysbiosis.

METHODS

Seventy-six participants were randomly assigned to receive either LRa05 (0.1 g 2 × 1010 CFU) (n = 38) or a placebo (n = 38) for 12 weeks. Baseline characteristics were recorded, and changes in glycated hemoglobin, fasting blood glucose, and other biochemical indices were assessed using repeated measures one-way analysis of variance. Additionally, gut microbiota diversity was analyzed through species accumulation and alpha and beta diversity metrics.

RESULTS

The intervention group showed statistically significant improvements in lipid profiles, particularly in high-density lipoprotein cholesterol levels, which increased significantly over time (P < 0.001). Additionally, fasting blood glucose was significantly reduced in the LRa05 group compared with the placebo group (P < 0.001). No significant changes were observed in glycated hemoglobin, insulin sensitivity, or systemic inflammatory markers such as C-reactive protein. Furthermore, gut microbiota analysis revealed significant shifts in composition following the intervention, particularly an increase in Bifidobacterium and a decrease in Bacillota, indicating beneficial effects on gut health.

CONCLUSION

This study demonstrated that the combination of Lactobacillus rhamnosus LRa05 and hypoglycemic medications positively impacted glycemic control, specifically reflected in improved levels of high-density lipoprotein and fasting blood glucose. Additionally, significant alterations in gut microbiota composition were observed in patients with T2DM, indicating a potential synergistic effect between gut health and blood glucose regulation.

Keywords: Lactobacillus rhamnosus; Type 2 diabetes; Glycated hemoglobin; Gut microbiota

Core Tip: Lactobacillus rhamnosus LRa05 is a probiotic that has shown potential in managing type 2 diabetes by improving glycemic control and gut microbiota composition. In a study involving 76 participants over 12 weeks, those who consumed LRa05 experienced significant reductions in fasting blood glucose levels and improved lipid profiles, particularly an increase in high-density lipoprotein cholesterol. The probiotic also positively influenced gut health by promoting beneficial bacteria such as Bifidobacterium while reducing potentially harmful Bacillota levels. Although there were no notable changes in insulin sensitivity or inflammation markers, the overall findings suggest that LRa05 plays a crucial role in diabetes management.