Airway Microbiome of Cystic Fibrosis Patients

Antwerp University Hospital (UZA)

Status: Active, not recruiting

Conditions: Cystic Fibrosis

Treatments: Biological: Probiotic throat spray

Study type: Interventional

Funder types: Other

Identifiers

NCT06057558

B3002021000106

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cystic fibrosis patients
• >6 years for intervention part of the study

Exclusion criteria

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Observational part of the study

No Intervention group

Description:

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 group

Description:

Daily use of a probiotic throat spray for 4 weeks

Treatment:

Biological: Probiotic throat spray