Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational part of the study | No Intervention | 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. | |
| Probiotic group | Experimental | Daily use of a probiotic throat spray for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic throat spray | Biological | Throat spray containing Lacticaseibacillus casei AMBR2 |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kim Van Hoorenbeeck | University Hospital, Antwerp | Principal Investigator |
| Sarah Lebeer, Prof. | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | 2650 | Belgium |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |