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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 704209958 |
| Sponsor | Capital Institute of Pediatrics |
| Funder | Beijing Medical Research Institute (BMR2019-11) |
- 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
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
Scientific
2 Yabao Road
Chaoyang District
Beijing
100020
China
| Phone | +86 (0)10 85695535 |
|---|---|
| yuanjing6216@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre cross-sectional cohort study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | The relationship between the lower respiratory tract microbiome and allergic respiratory tract diseases in children |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 01/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 68 |
| Total final enrolment | 68 |
| Key inclusion criteria | Children who visit the respiratory department and undergo bronchoscopy |
| Key exclusion criteria | 1. Diagnosis of pneumonia with specific pathogen infection such as fungus, virus, or mycoplasma 2. History of mechanical ventilation |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- China
Study participating centre
10020
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/05/2021 | 07/01/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
