The relationship between the microbes in the lower respiratory tract and allergic respiratory diseases in children

ISRCTN ISRCTN18302701
DOI https://doi.org/10.1186/ISRCTN18302701
Secondary identifying numbers 704209958
Submission date
30/09/2020
Registration date
06/10/2020
Last edited
07/01/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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?
Jinghua Cui
cuijinghua7910@hotmail.com

Contact information

Prof Jing Yuan
Scientific

2 Yabao Road
Chaoyang District
Beijing
100020
China

Phone +86 (0)10 85695535
Email yuanjing6216@163.com

Study information

Study designSingle-centre cross-sectional cohort study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Hospital
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleThe relationship between the lower respiratory tract microbiome and allergic respiratory tract diseases in children
Study objectivesA 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.
Ethics approval(s)Approved 20/06/2019, the medical ethics committee of the Capital Institute of Pediatrics (Beijing, China. +86 (0)8569 5535; shouerkyb@sina.com), ref: SHERLLM2019006
Health condition(s) or problem(s) studiedAllergic respiratory tract diseases in children
InterventionNucleic 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.
Intervention typeOther
Primary outcome measureThe 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 measuresThere are no secondary outcome measures
Overall study start date01/01/2018
Completion date01/05/2020

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants68
Total final enrolment68
Key inclusion criteriaChildren who visit the respiratory department and undergo bronchoscopy
Key exclusion criteria1. Diagnosis of pneumonia with specific pathogen infection such as fungus, virus, or mycoplasma
2. History of mechanical ventilation
Date of first enrolment01/01/2018
Date of final enrolment31/12/2018

Locations

Countries of recruitment

  • China

Study participating centre

The affiliated hospital of the Capital Institute of Pediatrics
Beijing
10020
China

Sponsor information

Capital Institute of Pediatrics
Research organisation

2 Yabao Road
Chaoyang District
Beijing
100020
China

Phone +86 (0)10 85695535
Email shouerkyb@sina.com
Website http://www.shouer.com.cn/en/web/detail.aspx?menuID=515&contentID=3536
ROR logo "ROR" https://ror.org/00zw6et16

Funders

Funder type

Research organisation

Beijing Medical Research Institute (BMR2019-11)

No information available

Results and Publications

Intention to publish date01/01/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 14/05/2021 07/01/2022 Yes No

Editorial Notes

07/01/2022: Publication reference added.
06/10/2020: Trial's existence confirmed by the medical ethics committee of the Capital Institute of Pediatrics.