Family research of microbes linked to respiratory infections

Not Applicable

• Conditions: nderstanding respiratory disease occurrence and transmission in households of healthy participants; Respiratory

• Registration Number: ISRCTN52814289
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-24
• Last Update Posted: 12 April 2021
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Adults aged 18-60 years and their children aged 28 days–17 years
2. Parent with fluent spoken English - to ensure a comprehensive understanding of the research project and the proposed involvement
3. Capacity of the parent to give informed consent

Exclusion Criteria

1. Taking daily medications that may affect the microbiome e.g. long-term antibiotics or immunosuppressants (including oral steroids)
2. Having received immunosuppressants or antibiotics in the preceding 28 days (recruitment can be delayed until the 28 days have passed)
3. History of respiratory infections requiring hospitalisation
4. Involved in a CTIMP or any trial that can affect the microbiome.
5. Disease or syndrome associated with altered immunity or altered respiratory or gut microbiome (including Crohn’s disease, ulcerative colitis or diabetes, and asthma or COPD) or other RTI conditions (including cystic fibrosis or bronchiectasis)
6. Current severe acute respiratory infection
7. Children with cognitive disabilities that lead to an inability to comply with study sampling

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Feasibility determined by the percentage (%) compliance measured as the number of samples stored in the fridge/freezer per volunteer to the total number of participants, where samples are collected every 2 weeks between baseline and 6 months<br> 2. Acceptability determined by the percentage (%) long-term acceptability measured using the practicality questionnaire to the total number of participants, where the questionnaire is completed every 2 weeks between baseline and 6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Microbiome taxonomic profiles will be generated by metagenomic 16S rRNA amplicon sequencing using Illumina technology of mucosal samples collected every 2 weeks between baseline and 6 months<br> 2. Virome will be determined by multiplex qPCR of mucosal samples collected every 2 weeks between baseline and 6 months<br> 3. Presence of AMR genes will be elucidated by conventional PCR of mucosal samples collected every 2 weeks between baseline and 6 months<br> 4. Data will be related to epidemiological information and episodes of respiratory tract infection collected by epidemiological questionnaires completed by participants every 2 weeks between baseline and 6 months<br>