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Research Article
Yan-jing Liu
Third Affiliated Clinical Hospital to Changchun University of Chinese Medicine
Corresponding Author
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Background: Bacterial 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.
Methods: This 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).
Discussion: The 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 registration: Chinese Clinical Trial Registry, ChiCTR1900027915. Date of last refreshed on 12/4/2019, http://www.chictr.org.cn/index.aspx.
Keywords
bacterial diarrhea, traditional Chinese medicine, antibiotic resistance, clinical efficacy evaluation, mechanism study
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Posted 02 Jun, 2021
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Editorial decision: Minor revision
On 07 Jun, 2021
Reviewer #2 agreed
On 06 Jun, 2021
Review #2 received
Received 06 Jun, 2021
Reviews received
Received 30 May, 2021
Reviewer #1 agreed
On 29 May, 2021
Review #1 received
Received 29 May, 2021
Reviewers invited
Invitations sent on 29 May, 2021
Editor assigned
On 29 May, 2021
First submitted
On 29 May, 2021
Submission checks complete
On 28 May, 2021
Version (no preprint)
Posted 24 May, 2021
Reviews received
Received 24 May, 2021
Reviewers invited
Invitations sent on 21 May, 2021
Editor assigned
On 16 May, 2021
First submitted
On 14 May, 2021
Editorial decision: Minor revision
On 08 May, 2021
This version was not preprinted
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Subject Areas
Integrative & Complementary Medicine
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Yan-jing Liu
Third Affiliated Clinical Hospital to Changchun University of Chinese Medicine
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version (no preprint)
Posted 02 Jun, 2021
This version was not preprinted
Version 1
Posted 02 Jun, 2021
No community comments so far
Editorial decision: Minor revision
On 07 Jun, 2021
Reviewer #2 agreed
On 06 Jun, 2021
Review #2 received
Received 06 Jun, 2021
Reviews received
Received 30 May, 2021
Reviewer #1 agreed
On 29 May, 2021
Review #1 received
Received 29 May, 2021
Reviewers invited
Invitations sent on 29 May, 2021
Editor assigned
On 29 May, 2021
First submitted
On 29 May, 2021
Submission checks complete
On 28 May, 2021
Version (no preprint)
Posted 24 May, 2021
Reviews received
Received 24 May, 2021
Reviewers invited
Invitations sent on 21 May, 2021
Editor assigned
On 16 May, 2021
First submitted
On 14 May, 2021
Editorial decision: Minor revision
On 08 May, 2021
This version was not preprinted
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Integrative & Complementary Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Bacterial 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.
Methods: This 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).
Discussion: The 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 registration: Chinese Clinical Trial Registry, ChiCTR1900027915. Date of last refreshed on 12/4/2019, http://www.chictr.org.cn/index.aspx.
Figure 1
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