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
ARTICLE HIGHLIGHTS
Research background

Hepatitis B cirrhosis (HBC) is a prevalent chronic disease associated with significant morbidity and mortality. Numerous studies have consistently demonstrated the occurrence of intestinal flora dysbiosis in patients diagnosed with HBC. Alterations in the composition of the intestinal flora can disrupt immune regulation, impair intestinal barrier function, and induce systemic inflammatory changes via the gut-liver axis, thereby hastening the progression of cirrhosis. Interventions utilizing microecological preparations hold immense significance in enhancing prognosis.

Research motivation

Although numerous individual probiotics have been documented in relation to HBC, the impact of the N1115 compound ready-to-eat Lactobacillus supplement in patients with HBC remains uncertain.

Research objectives

The primary objective was to assess the impact of the N1115 ready-to-consume lactic acid bacterial supplement on hepatic function, inflammation, and ascites in patients with HBC. This study aimed to investigate the therapeutic potential of the intestinal microecology in managing HBC. HBC patients were administered the N1115 ready-to-eat lactic acid bacterial supplement for 3 months, which resulted in a significant increase in intestinal microbial diversity and notable alterations in the composition of the intestinal microbiota. There was a remarkable improvement in liver function parameters and a decrease in the levels of inflammatory markers among the patients. This investigation offers novel insights into optimizing interventions targeting the intestinal microflora in individuals with HBC.

Research methods

This study included 160 HBC patients who were 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 Lactobacillus paracasei N1115 (LP N1115) supplementation along with 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.

Research results

The patients were assessed after 3 months of treatment with the N1115 ready-to-eat Lactobacillus supplement: (1) There were significant changes in the levels of albumin, creatinine, prothrombin time, international standard ratio, and C-reactive protein and in the Child-Turcotte-Pugh and Model for End-Stage Liver Disease scores before and after treatment in the intervention group; (2) the probability of recurrence of ascites in the intervention group was significantly lower than that in the nonintervention group; and (3) the diversity of the intestinal flora tended to increase after intervention with probiotics. At the phylum level, the proportion of Bacteroidetes increased significantly, and those of Firmicutes and Proteobacteria decreased significantly. At the genus level, the proportions of the potentially pathogenic bacteria Enterobacteriaceae_unclassified, Escherichia, Shigella, and Streptococcus decreased. In contrast, the proportions of Bacteroides, Bifidobacterium, Ruminococcus, Prevotella, and Lachnospiraceae incertae sedis increased.

Research conclusions

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

Research perspectives

Future studies should prioritize investigating the structural and metabolic alterations in the composition of intestinal biota among patients with various complications of HBC, along with elucidating their underlying mechanisms. To address these inquiries, our research group intends to conduct large-scale, long-term clinical trials.