With this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. To achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. Secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. Bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Throat spray containing Lacticaseibacillus casei AMBR2
Antwerp University Hospital
Edegem, Belgium
Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
Time frame: Change of microbial composition over one year (observational)
Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray
qPCR
Time frame: Transfer of probiotic over 6 weeks
Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray
16S rRNA amplicon sequencing and shotgun sequencing
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Influence on general health
A clinical evaluation by a specialist will be performed at the different consultations to assess general and respiratory health. A certified questionnaire including questions about the quality of life will also be filled in during each consultation.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in saliva, oropharynx and sputum samples, and cytokine and antibody levels in blood samples
qPCR and/or ELISA
Time frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
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