Objectives: The primary objective is to establish whether expiratory VOC analysis by electronic nose and GC-MS can: Ia) discriminate between patients (CF, PCD) with and without an exacerbation and Ib) discriminate between different microbial species…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures: relative changes in electronic nose sensors,
retention time, abundance and mass to charge ratio from GC-MS analysis.
Secondary outcome
Secondary outcomes: (change in) bacterial diversity.
Background summary
Chronic infection and inflammation of the airways are the leading causes of
morbidity in cystic fibrosis (CF) and primary ciliary dyskinesia (PCD). Early
detection and vigorous treatment of exacerbations are important in preserving
lung function and quality of life in these patients. Further, a better
understanding of airway infections and the development of exacerbations could
provide opportunities for novel strategies to maintain lung health. In this
longitudinal study, we investigate the dynamics of airway and intestinal
bacterial communities and exhaled volatile organic compounds. We aim to test
whether respiratory exacerbations in CF and PCD patients can be detected by
changes in the microbiome and molecular pattern recognition of volatile organic
compounds in exhaled breath.
Study objective
Objectives: The primary objective is to establish whether expiratory VOC
analysis by electronic nose and GC-MS can:
Ia) discriminate between patients (CF, PCD) with and without an exacerbation
and
Ib) discriminate between different microbial species
The secondary objective is to establish the dynamics of bacterial diversity in
the airways and intestines of patients with CF and PCD during stable disease
and during an exacerbation.
Study design
Longitudinal observational study during one year with collection of 5 exhaled
breath and microbiology samples.
Study burden and risks
The burden for the patients with CF and PCD in this longitudinal study is
limited to 3-monthly collection of sputum or cough swab samples, an exhaled
breath sample and a faeces sample. These measurements are completely safe and
without any health risks.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* CF diagnosis is based on: clinical symptoms in combination with an abnormal sweat test (chloride > 60 mmol/l) and/or identification of mutations in both alleles of the CFTR gene.
* PCD diagnosis is based on: a combination of clinical symptoms, abnormal movement of cilia on microscopic evaluation of respiratory epithelial biopsies and epithelial cell cultures, or identification of an ultra structural defect in the cilia by electron microscopy.
* * 6 years of age
* Stable respiratory disease for at least 6 weeks ( as determined by the treating physician)
* Ability to perform lung function measurement
Exclusion criteria
* Mental retardation
* Diabetes Mellitus (CF complication)
* Technical unsatisfactory performance of measurements
* On the waiting list for lung transplantation
* Participation in the PREVEC or VERTEX study (AMC)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41939.018.12 |
| Other | NTR voorlopig candidate number 13329 |