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Family research of microbes linked to respiratory infections

Establishment of home sampling as a surveillance tool for understanding the role of the human oral and nasal microbiota in respiratory disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN52814289
Enrollment
128
Registered
2020-09-24
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Understanding respiratory disease occurrence and transmission in households of healthy participants Respiratory

Interventions

Adult participants will collect non-invasive mucosal samples from themselves and their children at home every 2 weeks for 6 months. Participants will fill in questionnaires on demogra

Sponsors

Liverpool School of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 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

Secondary

MeasureTime frame
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 2. Virome will be determined by multiplex qPCR of mucosal samples collected every 2 weeks between baseline and 6 months 3. Presence of AMR genes will be elucidated by conventional PCR of mucosal samples collected every 2 weeks between baseline and 6 months 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

Countries

United Kingdom

Contacts

Public ContactElissavet Nikolaou
elissavet.nikolaou@lstmed.ac.uk+44 (0)151 702 9346

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026