Airway Microbiome of Cystic Fibrosis Patients

Not Applicable

Active, not recruiting

• Conditions: Cystic Fibrosis
• Interventions: Biological: Probiotic throat spray

• Registration Number: NCT06057558
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-09-26
• Study First Posted: 2023-09-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Probiotic throat spray	Daily use of a probiotic throat spray for 4 weeks

Primary Outcome Measures

Name	Time	Method
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	Transfer of probiotic over 6 weeks	qPCR

Secondary Outcome Measures

Name	Time	Method
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	Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks	qPCR and/or ELISA
Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray	Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks	16S rRNA amplicon sequencing and shotgun sequencing
Influence on general health	Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks	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.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Belgium