Abstract
BackgroundBacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. Antibiotic abuse and resistance are widespread problems worldwide, especially in China. We therefore designed a study to evaluate the clinical efficacy and mechanism of traditional Chinese medicine in alleviating the effects of antibiotic resistance in childhood bacterial diarrhea and enhancing the sensitivity of pathogenic bacteria to antibiotics.MethodsThis randomized, double-blind, placebo-controlled clinical trial has completed ChiCTR registration. The trial will randomly divide 120 children who meet the inclusion criteria into three groups: experimental group 1 (basic treatment + Gegen Qinlian decoction granules + Erbai drink placebo), experimental group 2 (basic treatment + Erbai drink granules + Gegen Qinlian decoction placebo), and control group (basic treatment + Gegen Qinlian decoction placebo + Erbai drink placebo). The main efficacy indicators will be antibiotic use rate and clinical cure rate, and the secondary efficacy indicators will be time to antibiotic intervention, effective rate, and course of treatment determined after 5 days. The following physical and chemical indicators will be measured: routine blood parameters, procalcitonin, C-reactive protein, electrocardiogram, liver and kidney function, electrolytes, routine urinalysis, routine stool analysis, and stool culture (including drug sensitivity).DiscussionThe results of this study may provide an objective clinical basis for the use of traditional Chinese medicine in managing antibiotic-resistant bacterial diarrhea in children, formulating relevant guidelines, and demonstrating the use of traditional Chinese medicine for reducing the use of antibiotics.Trial registrationChinese Clinical Trial Registry ChiCTR1900027915. Last refreshed on December 4, 2019.
Highlights
Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death
Wang et al [2] found that patients with bacterial diarrhea in Lanzhou were mainly infected with pathogenic Escherichia coli and Shigella, and Wang et al [3] found that Shigella was the main pathogen responsible for bacterial diarrhea in children under 14 years of age in Xi'an from 2004 to 2016, though the detection rate of Salmonella gradually increased over time
Based on the evaluation of the clinical efficacy of the traditional Chinese medicine (TCM) preparations and their combined application, we aim to investigate the mechanism of TCM in alleviating antibiotic resistance and enhancing the sensitivity of pathogenic bacteria to antibiotics
Summary
Bacterial infection is an important cause of diarrhea in children, potentially leading to malnutrition, growth and development disorders, and even death. We designed a study to evaluate the clinical efficacy and mechanism of traditional Chinese medicine in alleviating the effects of antibiotic resistance in childhood bacterial diarrhea and enhancing the sensitivity of pathogenic bacteria to antibiotics. Infectious diarrhea is one of the most common diseases worldwide, potentially causing malnutrition, growth and development disorders, and is the most common disease and the leading cause of death in children under the age of 5 years in developing countries. There is a need to evaluate the clinical efficacy and mechanism of traditional Chinese medicine in alleviating the resistance of childhood bacterial diarrhea to antibiotics and enhancing the antibiotic sensitivity of pathogenic bacteria. Cui et al [5] collected 10, 881 strains of various diarrhea pathogens in 16 provinces and cities in China, including seven genera, 22 strains, and 90 serotypes, including 7632 strains of Shigella (70.14%), 1351 strains of Vibrio (12.42%), 981 strains of Salmonella (9.02%), 341 strains (3.13%) of diarrheal E. coli, 302 strains (2.78%) of Aeromonas, 269 strains (2.47%) of Pseudomonas, and five strains (0.05%) of Yersinia enterocolitica
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