Clinical Trials Study
Copyright ©The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 21, 2024; 30(11): 1556-1571
Published online Mar 21, 2024. doi: 10.3748/wjg.v30.i11.1556
Effects of Lactobacillus paracasei N1115 on gut microbial imbalance and liver function in patients with hepatitis B-related cirrhosis
Yan-Chao Hu, Xiang-Chun Ding, Hui-Juan Liu, Wan-Long Ma, Xue-Yan Feng, Li-Na Ma
Yan-Chao Hu, Xiang-Chun Ding, Hui-Juan Liu, Wan-Long Ma, Xue-Yan Feng, Li-Na Ma, Department of Infectious Disease, General Hospital of Ningxia Medical University, Yinchuan 750004, Ningxia Hui Autonomous Region, China
Xiang-Chun Ding, Infectious Disease Clinical Research Center of Ningxia, Yinchuan 750004, Ningxia Hui Autonomous Region, China
Author contributions: Ding XC is the guarantor and designed the study; Hu YC participated in the acquisition, analysis, and interpretation of the data and drafted the initial manuscript; Liu HJ, Ma WL, and Feng XY participated in the acquisition and analysis of the data; and Ding XC and Ma LN critically revised the article for important intellectual content.
Supported by The Health System Research Project of Ningxia Hui Autonomous Region of China, No. 2022-NWKY-061.
Institutional review board statement: The study was reviewed and approved by the Hungarian National Review Board and the Institutional Review Board of the Ningxia Medical University.
Clinical trial registration statement: This study is registered at http://www.chictr.org.cn. The registration identification number is ChiCTRIIR17011061.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at [13619511768@163.com]. Participants consent for data sharing was not obtained but the presented data are anonymized and risk of identification is low. No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
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: Xiang-Chun Ding, MD, Doctor, Department of Infectious Disease, General Hospital of Ningxia Medical University, No. 804 Shengli Street, Yinchuan 750004, Ningxia Hui Autonomous Region, China. 13619511768@163.com
Received: December 17, 2023
Peer-review started: December 17, 2023
First decision: December 25, 2023
Revised: January 8, 2024
Accepted: March 4, 2024
Article in press: March 4, 2024
Published online: March 21, 2024
Processing time: 95 Days and 2 Hours
Abstract
BACKGROUND

Hepatitis B cirrhosis (HBC) is a chronic disease characterized by irreversible diffuse liver damage and aggravated by intestinal microbial imbalance and metabolic dysfunction. Although the relationship between certain single probiotics and HBC has been explored, the impact of the complex ready-to-eat Lactobacillus paracasei N1115 (LP N1115) supplement on patients with HBC has not been determined.

AIM

To compare the changes in the microbiota, inflammatory factor levels, and liver function before and after probiotic treatment in HBC patients.

METHODS

This study included 160 HBC patients diagnosed at the General Hospital of Ningxia Medical University between October 2018 and December 2020. Patients were randomly divided into an intervention group that received LP N1115 supplementation and routine treatment and a control group that received routine treatment only. Fecal samples were collected at the onset and conclusion of the 12-wk intervention period. The structure of the intestinal microbiota and the levels of serological indicators, such as liver function and inflammatory factors, were assessed.

RESULTS

Following LP N1115 intervention, the intestinal microbial diversity significantly increased in the intervention group (P < 0.05), and the structure of the intestinal microbiota was characterized by an increase in the proportions of probiotic microbes and a reduction in harmful bacteria. Additionally, the intervention group demonstrated notable improvements in liver function indices and significantly lower levels of inflammatory factors (P < 0.05).

CONCLUSION

LP N1115 is a promising treatment for ameliorating intestinal microbial imbalance in HBC patients by modulating the structure of the intestinal microbiota, improving liver function, and reducing inflammatory factor levels.

Keywords: Hepatitis B cirrhosis; N1115 ready-to-eat lactobacillus; Inflammation; Liver function; Lachnospiraceae incertae sedis; Probiotic

Core Tip: Intestinal microbial imbalance and metabolic dysfunction may accelerate the process of liver cirrhosis. We explored the role of probiotic intervention in patients with hepatitis B cirrhosis in this study. After an intervention with the N1115 ready-to-eat Lactobacillus supplement, we found the following significant changes: an increase in gut microbial diversity, structural changes in the microbiota favoring the growth of probiotic microbes, improvements in liver function, and decreases in inflammatory factor levels. We conclude that supplementation with the N1115 ready-to-eat Lactobacillus product may be a beneficial intervention in patients with cirrhosis.