Plain English Summary
Background and study aims
With the development of DNA sequencing technologies, it has been found that there are microbes similar to those in the upper respiratory tract (the nose and nasal cavity, the pharynx, and the larynx) present in the healthy human lower respiratory tract (LRT), including the lungs and bronchi. The aim of this study is to analyse the LRT microbiome and evaluate the relationship between this microbiome and allergic respiratory diseases in children.
Who can participate?
Children who visit the respiratory department and undergo bronchoscopy (a procedure where a tube is inserted through the nose or mouth, down the throat and into the windpipe, bronchi and bronchioles of the lungs)
What does the study involve?
Total IgE (antibody) levels are detected using a special protein analyser. The peripheral blood cell count is measured using an automatic blood analyser. DNA is extracted from samples of fluid taken during bronchoscopy and the microbiome is sequenced and analysed.
What are the possible benefits and risks of participating?
There are no benefits and risks of participating.
Where is the study run from?
The affiliated hospital of the Capital Institute of Pediatrics (China)
When is the study starting and how long is it expected to run for?
January 2018 to May 2020
Who is funding the study?
Beijing Medical Research Institute (China)
Who is the main contact?
Prof Jing Yuan
2 Yabao Road
+86 (0)10 85695535
The relationship between the lower respiratory tract microbiome and allergic respiratory tract diseases in children
A decrease in microbial diversity and change in composition could lead to an increase in allergic symptoms. The colonised microbiota of the lower respiratory tract (LRT) in children, especially that of Bacteriodetes and Streptococcus, show a certain correlation with early respiratory allergic diseases.
Approved 20/06/2019, the medical ethics committee of the Capital Institute of Pediatrics (Beijing, China. +86 (0)8569 5535; firstname.lastname@example.org), ref: SHERLLM2019006
Single-centre cross-sectional cohort study
Primary study design
Secondary study design
Cross sectional study
Patient information sheet
No participant information sheet available
Allergic respiratory tract diseases in children
Nucleic acid is extracted from samples of bronchoalveolar lavage fluid (BALF) of children taken during bronchoscopy treatment and the 16S rDNA gene is sequenced and analysed.
Primary outcome measure
The microbiome in BAFL measured using 16S rDNA sequenced on a MiSeq instrument (Illumina, Inc.) using a Miseq v2 reagent kit (Illumina, Inc.) at a single timepoint
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Children who visit the respiratory department and undergo bronchoscopy
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Diagnosis of pneumonia with specific pathogen infection such as fungus, virus, or mycoplasma
2. History of mechanical ventilation
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
The affiliated hospital of the Capital Institute of Pediatrics
Capital Institute of Pediatrics
2 Yabao Road
+86 (0)10 85695535
Beijing Medical Research Institute (BMR2019-11)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a peer-reviewed journal and sharing data on the National Genomics Data Center of the China National Center for Bioinformation (CNCB-NGDC).
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Jinghua Cui (cuijinghua7910@ hotmail.com). After the paper and the data are published, if consent is obtained from the author, the data can be shared with all who are interested in this study.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)