Airway Microbiome of Cystic Fibrosis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Biological: Probiotic throat spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystic fibrosis patients >6 years for intervention part of the study Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observational part of the study<br>During this part, we will collect saliva, throat and sputum samples from cystic fibrosis patients during their routine consultations in the hospital for one year. | |
| Experimental: Probiotic group<br>Daily use of a probiotic throat spray for 4 weeks | Biological: Probiotic throat spray<br>* Throat spray containing Lacticaseibacillus casei AMBR2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing |  | 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 | Transfer of probiotic over 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray | 16S rRNA amplicon sequencing and shotgun sequencing | 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. | 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 | Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome, lactobacilli, probiotics