Condition category
Respiratory
Date applied
30/09/2020
Date assigned
06/10/2020
Last edited
06/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
Jinghua Cui
cuijinghua7910@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jing Yuan

ORCID ID

Contact details

2 Yabao Road
Chaoyang District
Beijing
100020
China
+86 (0)10 85695535
yuanjing6216@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

704209958

Study information

Scientific title

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

Acronym

Study hypothesis

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.

Ethics approval

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

Study design

Single-centre cross-sectional cohort study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Allergic respiratory tract diseases in children

Intervention

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.

Intervention type

Other

Phase

Drug names

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

01/01/2018

Overall trial end date

01/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Children who visit the respiratory department and undergo bronchoscopy

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

68

Total final enrolment

68

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

01/01/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

China

Trial participating centre

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

Sponsor information

Organisation

Capital Institute of Pediatrics

Sponsor details

2 Yabao Road
Chaoyang District
Beijing
100020
China
+86 (0)10 85695535
shouerkyb@sina.com

Sponsor type

Research organisation

Website

http://www.shouer.com.cn/en/web/detail.aspx?menuID=515&contentID=3536

Funders

Funder type

Research organisation

Funder name

Beijing Medical Research Institute (BMR2019-11)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/10/2020: Trial's existence confirmed by the medical ethics committee of the Capital Institute of Pediatrics.